BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DJO SURGICAL

    DI: 00888912101059 · Model: 934-36-256 · Encore Medical, L.P.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DJO SURGICAL
    Primary DI
    00888912101059
    Version / Model
    934-36-256
    Company Name
    Encore Medical, L.P.
    Labeler DUNS
    154074504
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-08-07
    Public Version
    4
    Public Version Date
    2019-02-18
    Public Version Status
    Update
    Public Device Record Key
    c599eb21-183a-4242-aff2-db0162c40490

    Device Description

    LINER 50 NON-HOODED, HXL FMP, 36MM ID 56MM CUP OD, MP9

    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

    GMDN Terms

    Code Name
    43168 Non-constrained polyethylene acetabular liner

    Identifiers

    Type ID
    Primary 00888912101059

    Premarket Submissions

    Submission Number Supplement Number
    K072154 000
    K974093 000