BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Accu-Joint

    DI: 00850061635310 · Model: AJPI-P11-SUS · Accufix Surgical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Accu-Joint
    Primary DI
    00850061635310
    Version / Model
    AJPI-P11-SUS
    Catalog Number
    AJPI-P11-SUS
    Company Name
    Accufix Surgical, Inc.
    Labeler DUNS
    045694474
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-11-11
    Public Version
    1
    Public Version Date
    2024-11-19
    Public Version Status
    New
    Public Device Record Key
    991e352f-aa8b-4d12-95a6-ab4a5a4d2155

    Device Description

    Accu-Joint Hemi Implant - Phalangeal 11mm - SUS

    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
    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
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    KWD Prosthesis, Toe, Hemi-, Phalangeal

    GMDN Terms

    Code Name
    33696 Partial metatarsophalangeal joint prosthesis

    Identifiers

    Type ID
    Primary 00850061635310