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    FDA UDI In Commercial Distribution 🇺🇸 United States

    LINK Instrument

    DI: 04026575423194 · Model: 175-201/09 · WALDEMAR LINK GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    LINK Instrument
    Primary DI
    04026575423194
    Version / Model
    175-201/09
    Catalog Number
    175-201/09
    Company Name
    WALDEMAR LINK GmbH & Co. KG
    Labeler DUNS
    315675488
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-23
    Public Version
    1
    Public Version Date
    2018-12-24
    Public Version Status
    New
    Public Device Record Key
    a75fc14c-189d-415b-a5aa-92f53e9bc430

    Device Description

    Bone Compressor

    Device Characteristics

    Single Use
    No
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
    MEH Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

    GMDN Terms

    Code Name
    36167 Orthopaedic broach

    Identifiers

    Type ID
    Primary 04026575423194

    Premarket Submissions

    Submission Number Supplement Number
    K161840 000