BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Prase-C Anterior Cervical Plate System

    DI: 08800167316974 · Model: C121-3720 · GBS Commonwealth Co.,Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Prase-C Anterior Cervical Plate System
    Primary DI
    08800167316974
    Version / Model
    C121-3720
    Company Name
    GBS Commonwealth Co.,Ltd.
    Labeler DUNS
    694609156
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-09-30
    Public Version
    2
    Public Version Date
    2023-09-18
    Public Version Status
    Update
    Public Device Record Key
    78d7dff1-8097-4344-923c-f9ec0862ec4a

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    KWP Appliance, Fixation, Spinal Interlaminal

    GMDN Terms

    Code Name
    46653 Spinal fixation plate, non-bioabsorbable

    Identifiers

    Type ID
    Primary 08800167316974

    Premarket Submissions

    Submission Number Supplement Number
    K211205 000