BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GemcisionTM Paracentesis, Super Sharp, 1mm Width, 30°

    DI: 00840096215090 · Model: 7990-P1 · KATALYST SURGICAL LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GemcisionTM Paracentesis, Super Sharp, 1mm Width, 30°
    Primary DI
    00840096215090
    Version / Model
    7990-P1
    Company Name
    KATALYST SURGICAL LLC
    Labeler DUNS
    007883297
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-03-31
    Public Version
    1
    Public Version Date
    2023-04-10
    Public Version Status
    New
    Public Device Record Key
    9381b484-4c6c-473d-a272-0c9665e58bf1

    Device Description

    GemcisionTM Paracentesis, Super Sharp, 1mm Width, 30°

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    HNN Knife, Ophthalmic

    GMDN Terms

    Code Name
    32764 Ophthalmic knife, reusable

    Identifiers

    Type ID
    Primary 00840096215090