BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Inion OTPS BioRestore™

    DI: M224BRS16009 · Model: 1 · Inion Oy
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Inion OTPS BioRestore™
    Primary DI
    M224BRS16009
    Version / Model
    1
    Catalog Number
    BRS-1600
    Company Name
    Inion Oy
    Labeler DUNS
    367994657
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-02-07
    Public Version
    4
    Public Version Date
    2023-10-02
    Public Version Status
    Update
    Public Device Record Key
    f1d5513c-7087-4dd8-8799-5ce83ead44d2
    Distribution End Date
    2028-10-01

    Device Description

    Block 30 x 20 x 8 mm

    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
    MQV FILLER, BONE VOID, CALCIUM COMPOUND
    LYC Bone grafting material, synthetic

    GMDN Terms

    Code Name
    16966 Synthetic bone graft

    Identifiers

    Type ID
    Primary M224BRS16009

    Premarket Submissions

    Submission Number Supplement Number
    K070784 000
    K070998 000