Premier Weekly Test 2

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| By Xulfi
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Xulfi
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Quizzes Created: 1 | Total Attempts: 144
| Attempts: 144
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  • 1/20 Questions

    Choose the Wrongly Validated Manufacturer from the following

    • TELEFLEX MEDICAL INCORPORATED
    • CARDINAL HEALTH 200, LLC
    • THERMO FISHER SCIENTIFIC
    • ANGIODYNAMICS INC
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About This Quiz

Premier Weekly Test 2 evaluates knowledge on medical device validation, including manufacturer validation, volume\/weight categories, ergonomic locations, and pediatric considerations. It tests understanding of regulatory codes and standards, essential for professionals in healthcare and compliance.

Premier Weekly Test 2 - Quiz

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  • 2. 

    Which of the following will not go in VALIDATED VOLUME/WEIGHT:

    • Millilitres

    • Pounds

    • French

    • Ounce

    Correct Answer
    A. French
    Explanation
    The term "VALIDATED VOLUME/WEIGHT" suggests that it refers to units of measurement used to quantify volume or weight. Millilitres, Pounds, and Ounce are all commonly used units to measure volume or weight. However, "French" does not represent a unit of measurement for volume or weight. Therefore, it will not go in VALIDATED VOLUME/WEIGHT.

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  • 3. 

    Choose the wrong term with regards to Ergonomic Location:

    • Abdominal

    • Cortical

    • Femoral

    • Trochanter

    Correct Answer
    A. Trochanter
    Explanation
    The term "Trochanter" is the wrong term with regards to Ergonomic Location. The trochanter is a bony prominence on the femur bone, not a location in the body. Abdominal refers to the area of the body between the chest and the pelvis. Cortical refers to the outer layer of an organ or structure. Femoral refers to the thigh area. Therefore, trochanter is the incorrect term in this context.

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  • 4. 

    For which of the following will Validated Pediatrics be Yes:

    • Adolescent

    • Infant

    • Only Option 2

    • Both Option 1 and Option 2

    Correct Answer
    A. Both Option 1 and Option 2
    Explanation
    Validated Pediatrics will be Yes for both adolescents and infants.

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  • 5. 

    For Bone Plates - Narrow, Wide, Standard will go in :

    • VALIDATED SHAPE

    • VALIDATED SIZE/DIAMETER

    • VALIDATED PRIMARY DIMENSIONS

    • VALIDATED PRIMARY CHARACTERISTIC

    Correct Answer
    A. VALIDATED SHAPE
    Explanation
    The correct answer is VALIDATED SHAPE. This is because bone plates come in different shapes, such as narrow, wide, and standard, which are validated and approved for use in medical procedures. The shape of the bone plate is an important factor in determining its effectiveness and compatibility with the patient's anatomy. Therefore, validating the shape ensures that the bone plate will fit properly and provide the necessary support and stability for the bone during the healing process.

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  • 6. 

    "Orange Book" is used to capture which of the following information ?

    • GLN Number

    • GTIN Number

    • NDC Code

    • DEA Code

    Correct Answer
    A. DEA Code
    Explanation
    The "Orange Book" is used to capture the DEA Code. The DEA Code refers to the Drug Enforcement Administration Code, which is a unique identifier assigned to controlled substances by the DEA. The Orange Book is a publication by the FDA that lists approved drug products with therapeutic equivalence evaluations. It includes information about the DEA Code for controlled substances, allowing for proper identification and regulation of these drugs.

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  • 7. 

    For which of the following will Validated Implant be NO:

    • Temporary Aneurysm Clips

    • Mitral valve

    • Bone screw

    • Intraocular lens

    Correct Answer
    A. Temporary Aneurysm Clips
    Explanation
    Validated Implant refers to a medical device that has undergone a thorough validation process to ensure its safety and effectiveness. In the case of temporary aneurysm clips, these are used during neurosurgical procedures to clamp off blood vessels temporarily. Since these clips are not intended to be permanently implanted in the body, they may not undergo the same level of validation as other implants. Therefore, the answer is that Validated Implant will be NO for Temporary Aneurysm Clips.

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  • 8. 

    Choose the Wrong Statement

    • NDC Code has 11 digits

    • NDC Code can also have 10 digits

    • GLN number has 13 digits

    • GLN number can also have 12 digits

    Correct Answer
    A. GLN number can also have 12 digits
    Explanation
    The given statement suggests that the GLN number can have 12 digits, which is incorrect. The GLN number always has 13 digits and cannot have any other number of digits.

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  • 9. 

    "Sterilizable" should be captured in :

    • VALIDATED STERILITY

    • VALIDATED REUSABILITY

    • VALIDATED PACKAGED AS STERILE

    • None of the Above

    Correct Answer
    A. VALIDATED REUSABILITY
    Explanation
    The term "sterilizable" refers to something that can be sterilized, meaning it can be made free from bacteria and other microorganisms. In the given options, "VALIDATED REUSABILITY" is the only choice that captures the idea of something being able to be used again after being sterilized. "VALIDATED STERILITY" refers to something that has been proven to be sterile, while "VALIDATED PACKAGED AS STERILE" refers to something that has been packaged in a sterile manner. Therefore, the correct answer is "VALIDATED REUSABILITY" as it aligns with the concept of sterilizability.

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  • 10. 

    For a Stent, Drug Eluting will go in :

    • VALIDATED PRIMARY CHARACTERISTIC

    • VALIDATED SECONDARY CHARACTERISTIC

    • ITEM CLARIFIER

    • VALIDATED OTHERS

    Correct Answer
    A. ITEM CLARIFIER
  • 11. 

    Which of the following values in Validated Size is wrong

    • 2XL

    • XS

    • XXXL

    • All of the above

    Correct Answer
    A. All of the above
    Explanation
    The answer "All of the above" is correct because it states that all the values mentioned in the given list (2XL, XS, XXXL) are wrong in terms of Validated Size. This means that none of these values are considered valid or correct in the context of Validated Size.

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  • 12. 

    Choose the correct Brand Name

    • MILTEX

    • FLEXIMA

    • DEBAKEY

    • MACCONKEY

    Correct Answer
    A. FLEXIMA
    Explanation
    FLEXIMA is the correct brand name out of the options given. The other options (MILTEX, DEBAKEY, and MACCONKEY) do not sound like brand names and are not commonly associated with any specific products or companies. FLEXIMA, on the other hand, has a more distinctive and recognizable sound to it, making it a more likely choice for a brand name.

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  • 13. 

    "Forearm or wrist or thumb orthopedic softgoods" - for this category, the correct type would be:

    • Forearm

    • Softgood

    • Wrist

    • Orthopedic

    Correct Answer
    A. Orthopedic
    Explanation
    The correct answer is "Orthopedic" because the category mentioned in the question is "Forearm or wrist or thumb orthopedic softgoods." Therefore, the correct type for this category would be orthopedic, as it refers to medical devices or products related to the treatment of musculoskeletal disorders or injuries.

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  • 14. 

    If website says products come in a Case of 10 Units- Which of the following is correct ?

    • Validated Pkg String: 1CA/10EA

    • Validated Alt Pkg String: 1CA/10UN

    • Both Option 1 and Option 2

    • None of the Above

    Correct Answer
    A. Both Option 1 and Option 2
    Explanation
    Both Option 1 and Option 2 are correct because they both represent the same information. "1CA/10EA" means that there is 1 case containing 10 units, and "1CA/10UN" means the same thing - 1 case with 10 units. Therefore, both options accurately represent the fact that the products come in a case of 10 units.

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  • 15. 

    If product is kit and MSDS sheets are available for the various components of KIT, then

    • MSDS for the primary product should be populated

    • Multiple MSDS for the components can be populated

    • Need not capture MSDS

    • None of the Above

    Correct Answer
    A. Multiple MSDS for the components can be populated
    Explanation
    If a product is a kit and MSDS sheets are available for the various components of the kit, it means that each component may have different hazardous properties and safety information. Therefore, it is necessary to populate multiple MSDS for the components to ensure that all the relevant safety information is provided for each component. This will help users to understand the potential hazards associated with each component and take appropriate safety measures.

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  • 16. 

    A 10 Digit NDC code is available in:

    • 4-4-2 Format

    • 5-3-2 Format

    • 5-4-1 Format

    • All the three formats

    Correct Answer
    A. All the three formats
    Explanation
    The correct answer is all the three formats because a 10-digit NDC code can be found in any of the given formats: 4-4-2 format, 5-3-2 format, and 5-4-1 format. This means that a 10-digit NDC code can have four digits followed by four digits and then two digits, or it can have five digits followed by three digits and then two digits, or it can have five digits followed by four digits and then one digit. Therefore, all three formats are valid for a 10-digit NDC code.

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  • 17. 

    For a Supplemental Formula, the Word "Orange" indicates

    • Color

    • Flavor

    • Both Option 1 and Option 2

    • None of the Above

    Correct Answer
    A. Flavor
    Explanation
    The word "Orange" in a Supplemental Formula indicates flavor. This means that the formula contains an orange flavor, which could be used to enhance the taste of the supplement. The word "Orange" does not refer to the color of the formula, but rather to the specific taste that it provides.

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  • 18. 

    Which of the following match is wrong:

    • Undyed- Color

    • 3/8 Circle- Shape

    • Unisex- Size

    • Distal- Ergonomic Location

    Correct Answer
    A. Unisex- Size
    Explanation
    The given match "Unisex- Size" is wrong because "Unisex" refers to a style or design that is suitable for both males and females, and it is not related to size. Size refers to the dimensions or measurements of an object or garment. Therefore, the match between "Unisex" and "Size" is incorrect.

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  • 19. 

    Chromic Gut, Plain Gut with relation to Sutures should be Captured in

    • VALIDATED COMPOSITION

    • VALIDATED BRAND NAME

    • VALIDATED PRIMARY CHARACTERISTIC

    • ITEM CLARIFIER

    Correct Answer
    A. VALIDATED BRAND NAME
    Explanation
    The correct answer is VALIDATED BRAND NAME because both Chromic Gut and Plain Gut are types of sutures, and sutures are typically identified by their brand names. The term "validated" suggests that the brand name has been approved or confirmed as appropriate for use in the context of sutures. Therefore, capturing Chromic Gut and Plain Gut in a validated brand name would ensure that the specific types of sutures are accurately identified and used.

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  • 20. 

    In case of Stents, which attribute is wrongly matched

    • Coronary- Type

    • Drug Eluting-Item Clarifier

    • Rapid Exchange- Primary Characteristic

    • Balloon Expanding- Secondary Characteristic

    Correct Answer
    A. Balloon Expanding- Secondary Characteristic
    Explanation
    The attribute "Balloon Expanding" is wrongly matched with the term "Secondary Characteristic" in the context of stents. This implies that the expansion of the balloon is not considered a secondary characteristic of stents.

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Quiz Review Timeline (Updated): Aug 13, 2024 +

Our quizzes are rigorously reviewed, monitored and continuously updated by our expert board to maintain accuracy, relevance, and timeliness.

  • Current Version
  • Aug 13, 2024
    Quiz Edited by
    ProProfs Editorial Team
  • Apr 16, 2014
    Quiz Created by
    Xulfi

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