BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Geri-Gentle

    DI: 10369771000167 · Model: 21-515 · GERI-GENTLE CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    20

    Basic Information

    Brand Name
    Geri-Gentle
    Primary DI
    10369771000167
    Version / Model
    21-515
    Company Name
    GERI-GENTLE CORPORATION
    Labeler DUNS
    361663839
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    20
    Record Status
    Published
    Publish Date
    2016-11-10
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    74a321f0-a2ea-4979-92af-84e45031906a

    Device Description

    URETHRAL CATHETER TRAY

    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
    Yes
    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
    OHR Catheter Care Tray

    GMDN Terms

    Code Name
    45605 Single-administration urethral catheterization kit, single-use

    Identifiers

    Type ID
    Primary 10369771000167
    Unit of Use 50369771000160