BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Disposable Pre-calibrated Biopsy Needle

    DI: 04048223099018 · Model: 42051-01 · Pajunk GmbH Medizintechnologie
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Disposable Pre-calibrated Biopsy Needle
    Primary DI
    04048223099018
    Version / Model
    42051-01
    Catalog Number
    42051-01
    Company Name
    Pajunk GmbH Medizintechnologie
    Labeler DUNS
    317654283
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-01-29
    Public Version
    1
    Public Version Date
    2025-02-06
    Public Version Status
    New
    Public Device Record Key
    0115a747-7d7b-4aa5-a809-5bcd4d23cea1

    Device Description

    Disposable Pre-calibrated Biopsy Needle 2.1 x 257 mm

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HAW Neurological stereotaxic Instrument

    GMDN Terms

    Code Name
    38563 Brain biopsy procedure kit

    Identifiers

    Type ID
    Package 04048223108857
    Primary 04048223099018

    Customer Contacts

    Phone
    +1 770-493-6832
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Length 257.0 Millimeter
    Outer Diameter 2.1 Millimeter

    Storage Conditions

    Type
    Storage Environment Humidity
    Temperature Range
    20 – 65 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    10 – 30 Degrees Celsius