BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NA

    DI: 07613327129243 · Model: 78-40100 · Stryker Leibinger GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NA
    Primary DI
    07613327129243
    Version / Model
    78-40100
    Catalog Number
    78-40100
    Company Name
    Stryker Leibinger GmbH & Co. KG
    Labeler DUNS
    316153956
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-09-24
    Public Version
    7
    Public Version Date
    2023-09-18
    Public Version Status
    Update
    Public Device Record Key
    9bab27a2-734d-4604-975d-f1c2022e2da2

    Device Description

    PEEK CUSTOMIZED-CRANIOFACIAL

    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 Safe
    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    GWO Plate, cranioplasty, preformed, alterable

    GMDN Terms

    Code Name
    46642 Craniofacial fixation plate, non-bioabsorbable, non-customized

    Identifiers

    Type ID
    Primary 07613327129243

    Premarket Submissions

    Submission Number Supplement Number
    K152076 000