BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Standard Tibial Insert

    DI: B0462203001270 · Model: 7x12 · SIGNAL MEDICAL CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Standard Tibial Insert
    Primary DI
    B0462203001270
    Version / Model
    7x12
    Catalog Number
    22-03-00-12-7
    Company Name
    SIGNAL MEDICAL CORPORATION
    Labeler DUNS
    169289308
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-03-22
    Public Version
    1
    Public Version Date
    2019-04-01
    Public Version Status
    New
    Public Device Record Key
    ef8b3e04-1fb9-49e1-8f19-f78ad59c778a

    Device Description

    Symmetric Total Knee Standard Tibial Insert Size 7x12

    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
    Yes
    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
    JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

    GMDN Terms

    Code Name
    46585 Tibial insert

    Identifiers

    Type ID
    Primary B0462203001270

    Customer Contacts

    Phone
    8103647070
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K080199 000