BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PenBlade Safety Scalpel

    DI: 10853624005022 · Model: #15 Blade · ZIEN MEDICAL TECHNOLOGIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    10

    Basic Information

    Brand Name
    PenBlade Safety Scalpel
    Primary DI
    10853624005022
    Version / Model
    #15 Blade
    Catalog Number
    PB-M-15
    Company Name
    ZIEN MEDICAL TECHNOLOGIES, INC.
    Labeler DUNS
    017535668
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2020-09-21
    Public Version
    1
    Public Version Date
    2020-09-29
    Public Version Status
    New
    Public Device Record Key
    0a5d6ffe-2eac-4f31-b2f5-aef8e12dd575

    Device Description

    The PenBlade Safety Scalpel is a scalpel which contains a mechanism to extend and retract a blade between an exposed and a retracted safe position.

    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
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    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
    GDX Scalpel, One-Piece

    GMDN Terms

    Code Name
    47569 Scalpel, single-use

    Identifiers

    Type ID
    Package 20853624005029
    Primary 10853624005022
    Package 30853624005026
    Unit of Use 00853624005025