BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Arthrex®

    DI: 00888867108554 · Model: AR-513-RJ10 · ARTHREX, INC.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Arthrex®
    Primary DI
    00888867108554
    Version / Model
    AR-513-RJ10
    Catalog Number
    AR-513-RJ10
    Company Name
    ARTHREX, INC.
    Labeler DUNS
    131747628
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-02-15
    Public Version
    5
    Public Version Date
    2024-01-10
    Public Version Status
    Update
    Public Device Record Key
    c26ddfe8-78d7-4e7b-9647-d4b49fc6a3d1

    Device Description

    IBAL TKA,BEARING IMP,CR,SZ 8,10MM

    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
    MR Conditional
    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
    MBH PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
    KRR PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
    HSX PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

    GMDN Terms

    Code Name
    33666 Uncoated knee tibia/insert prosthesis

    Identifiers

    Type ID
    Primary 00888867108554
    Secondary M150AR513RJ101

    Customer Contacts

    Phone
    +1(800)934-4404
    Email
    [email protected]