BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Strauss Surgical

    DI: 00851925007236 · Model: STS-ACC-6000-BRGA-002 · AMERICAN MEDICAL ENDOSCOPY, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Strauss Surgical
    Primary DI
    00851925007236
    Version / Model
    STS-ACC-6000-BRGA-002
    Company Name
    AMERICAN MEDICAL ENDOSCOPY, INC.
    Labeler DUNS
    024725124
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-12-19
    Public Version
    4
    Public Version Date
    2024-07-25
    Public Version Status
    Update
    Public Device Record Key
    b3c1ee67-54aa-4d95-a781-02033b0f7605

    Device Characteristics

    Single Use
    No
    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 Safe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    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
    FGB Ureteroscope And Accessories, Flexible/Rigid

    GMDN Terms

    Code Name
    61792 Endoscope air/water valve, reusable

    Identifiers

    Type ID
    Primary 00851925007236

    Premarket Submissions

    Submission Number Supplement Number
    K992527 000