BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    andorate® Universal Endoscope Tip Guard

    DI: 04897106953547 · Model: GAR107 · GA Health Company Limited
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    andorate® Universal Endoscope Tip Guard
    Primary DI
    04897106953547
    Version / Model
    GAR107
    Company Name
    GA Health Company Limited
    Labeler DUNS
    686908512
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-01-28
    Public Version
    2
    Public Version Date
    2023-02-20
    Public Version Status
    Update
    Public Device Record Key
    e95bb75d-30e9-44a9-892d-37e97f14b80a

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OCU Endoscopic Storage Cover

    GMDN Terms

    Code Name
    63247 Surgical instrument guard, single-use

    Identifiers

    Type ID
    Package 14897106953544
    Primary 04897106953547
    Package 24897106953541