BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tension Bolt

    DI: 09120069811742 · Model: 680877 · I.T.S. GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Tension Bolt
    Primary DI
    09120069811742
    Version / Model
    680877
    Catalog Number
    680877
    Company Name
    I.T.S. GmbH
    Labeler DUNS
    303456917
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-08
    Public Version
    1
    Public Version Date
    2018-12-10
    Public Version Status
    New
    Public Device Record Key
    0c81ad65-0384-45fe-ac78-a472b4984cf5

    Device Description

    Tension Bolt, Ulna Osteotomy Plate

    Device Characteristics

    Single Use
    No
    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
    MR Safe
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    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
    HTN Washer, Bolt Nut

    GMDN Terms

    Code Name
    16077 Orthopaedic bone bolt

    Identifiers

    Type ID
    Primary 09120069811742