BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DJO SURGICAL

    DI: 00888912115162 · Model: 324-01-103 · DJO, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DJO SURGICAL
    Primary DI
    00888912115162
    Version / Model
    324-01-103
    Company Name
    DJO, LLC
    Labeler DUNS
    081840873
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-30
    Public Version
    4
    Public Version Date
    2019-12-11
    Public Version Status
    Update
    Public Device Record Key
    4c2c1eb0-b6fa-4165-90af-295b8ae27fcf

    Device Description

    BASEPLATE, STEMMED, NON POROUS TIBIAL COCR SIZE3R

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JWH PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

    GMDN Terms

    Code Name
    32832 Uncoated knee tibia prosthesis, metallic

    Identifiers

    Type ID
    Primary 00888912115162

    Premarket Submissions

    Submission Number Supplement Number
    K923277 000