BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MEDPOR

    DI: 07613252085003 · Model: 8321 · Stryker Leibinger GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MEDPOR
    Primary DI
    07613252085003
    Version / Model
    8321
    Catalog Number
    8321
    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
    4
    Public Version Date
    2020-10-12
    Public Version Status
    Update
    Public Device Record Key
    f3889c68-c0e1-4b47-abc1-689aeac9af36

    Device Description

    Chin Two Piece-Medium

    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
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FWP PROSTHESIS, CHIN, INTERNAL

    GMDN Terms

    Code Name
    35261 Chin prosthesis

    Identifiers

    Type ID
    Primary 07613252085003

    Premarket Submissions

    Submission Number Supplement Number
    K922489 000

    Device Sizes

    Type Value Unit Text
    Width 56.0 Millimeter
    Height 36.0 Millimeter
    Device Size Text, specify Thickness: 7.0 Millimeter