BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DJO SURGICAL

    DI: 00888912078863 · Model: 425-98-013S · DJO, LLC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DJO SURGICAL
    Primary DI
    00888912078863
    Version / Model
    425-98-013S
    Company Name
    DJO, LLC
    Labeler DUNS
    081840873
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-07-05
    Public Version
    4
    Public Version Date
    2018-09-27
    Public Version Status
    Update
    Public Device Record Key
    eeb2f915-c5a9-4f09-8c11-249d7c0d48f1

    Device Description

    LINEAR STANDARD POROUS W/ P2 SZ 13

    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
    LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

    GMDN Terms

    Code Name
    33581 Coated hip femur prosthesis, modular

    Identifiers

    Type ID
    Primary 00888912078863

    Premarket Submissions

    Submission Number Supplement Number
    K120241 000