BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FacetLink System

    DI: 04026575421152 · Model: 80-1005/06L · WALDEMAR LINK GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FacetLink System
    Primary DI
    04026575421152
    Version / Model
    80-1005/06L
    Catalog Number
    80-1005/06L
    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
    2015-11-01
    Public Version
    4
    Public Version Date
    2023-09-18
    Public Version Status
    Update
    Public Device Record Key
    ed80e6d3-2bdf-4b26-9c2c-ac13054f214c

    Device Description

    HEMI Implant

    Device Characteristics

    Single Use
    Yes
    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
    MR Conditional
    Direct Marking Exempt
    Yes
    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
    MRW System, Facet Screw Spinal Device

    GMDN Terms

    Code Name
    61670 Implantable bone washer

    Identifiers

    Type ID
    Primary 04026575421152

    Premarket Submissions

    Submission Number Supplement Number
    K150223 000

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify left, large buttress, 6mm