BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Austin Medical, Inc

    DI: 00850017635913 · Model: GST002-07 · AUSTIN MEDICAL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Austin Medical, Inc
    Primary DI
    00850017635913
    Version / Model
    GST002-07
    Catalog Number
    GST002-07
    Company Name
    AUSTIN MEDICAL
    Labeler DUNS
    010058700
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-12-22
    Public Version
    1
    Public Version Date
    2025-12-30
    Public Version Status
    New
    Public Device Record Key
    9477c02c-21a9-48d6-a065-41e398c98c0c
    Distribution End Date
    2025-12-22

    Device Description

    EGD Pack

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LRO General Surgery Tray

    GMDN Terms

    Code Name
    33961 General surgical procedure kit, non-medicated, single-use

    Identifiers

    Type ID
    Primary 00850017635913