BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OrthoMedFlex

    DI: M7161111243500 · Model: 111124350 · ORTHOMEDFLEX LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OrthoMedFlex
    Primary DI
    M7161111243500
    Version / Model
    111124350
    Catalog Number
    111-12-4350
    Company Name
    ORTHOMEDFLEX LLC
    Labeler DUNS
    034442726
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-06-21
    Public Version
    2
    Public Version Date
    2020-09-09
    Public Version Status
    Update
    Public Device Record Key
    c04a7291-bca3-4ca3-93e0-2176a0f33452

    Device Description

    50mm Acetabular Cup (3-Hole) HA

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

    GMDN Terms

    Code Name
    43167 Acetabular shell

    Identifiers

    Type ID
    Primary M7161111243500