BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    APOLLO Ankle Fracture Plating System

    DI: 18435711003344 · Model: F3-0005-004 · Glw, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    APOLLO Ankle Fracture Plating System
    Primary DI
    18435711003344
    Version / Model
    F3-0005-004
    Catalog Number
    F3-0005-004
    Company Name
    Glw, Inc.
    Labeler DUNS
    081102081
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-01-30
    Public Version
    3
    Public Version Date
    2026-03-12
    Public Version Status
    Update
    Public Device Record Key
    9c032a30-01e8-4d08-ba6d-8075072f172c

    Device Description

    APOLLO Ankle Fracture Plates / Syndesmotic Plate / 4 holes

    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
    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HRS Plate, Fixation, Bone

    GMDN Terms

    Code Name
    46647 Orthopaedic fixation plate, non-bioabsorbable

    Identifiers

    Type ID
    Primary 18435711003344