BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DJO SURGICAL

    DI: 00190446259039 · Model: 508-07-000 · Encore Medical, L.P.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DJO SURGICAL
    Primary DI
    00190446259039
    Version / Model
    508-07-000
    Company Name
    Encore Medical, L.P.
    Labeler DUNS
    154074504
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-03-05
    Public Version
    2
    Public Version Date
    2018-07-06
    Public Version Status
    New
    Public Device Record Key
    5c67ab55-c492-4996-926c-6a0b3ba8cf95

    Device Description

    ALTIVATE ANTAOMIC TO REVERSE CONVERSION MODULE, NEUTRAL

    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
    PHX shoulder prosthesis, reverse configuration
    KWS PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
    PAO prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented

    GMDN Terms

    Code Name
    33711 Total reverse shoulder prosthesis

    Identifiers

    Type ID
    Primary 00190446259039

    Premarket Submissions

    Submission Number Supplement Number
    K173073 000