BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OsteoGen Block

    DI: 00855286006358 · Model: OBB101517 · Impladent, Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OsteoGen Block
    Primary DI
    00855286006358
    Version / Model
    OBB101517
    Company Name
    Impladent, Ltd.
    Labeler DUNS
    199838400
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-22
    Public Version
    2
    Public Version Date
    2024-02-19
    Public Version Status
    Update
    Public Device Record Key
    96cebe6f-3b5e-42f9-a223-9689553d8fcc

    Device Description

    OsteoGen Block. OsteoGen bone graft combined with a bovine achilles tendon carrier

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NPM Bone Grafting Material, Animal Source

    GMDN Terms

    Code Name
    46543 Composite bone graft

    Identifiers

    Type ID
    Package 00855286006341
    Primary 00855286006358

    Premarket Submissions

    Submission Number Supplement Number
    K090794 000