BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Smart Correction

    DI: B562SC8TLR10H0 · Model: SC-8TLR10H · Wishbone Medical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Smart Correction
    Primary DI
    B562SC8TLR10H0
    Version / Model
    SC-8TLR10H
    Catalog Number
    SC-8TLR10H
    Company Name
    Wishbone Medical, Inc.
    Labeler DUNS
    062355158
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-10-21
    Public Version
    3
    Public Version Date
    2023-04-03
    Public Version Status
    Update
    Public Device Record Key
    242045ae-0c17-4c67-8816-e203c6341697
    Distribution End Date
    2023-02-27

    Device Description

    8Nm Torque Limiting Ratchet Wrench and 10mm Hex Bolt Socket - Non-Sterile

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Serial Number
    No
    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
    HXC Wrench

    GMDN Terms

    Code Name
    48011 External orthopaedic fixation system, single-use

    Identifiers

    Type ID
    Primary B562SC8TLR10H0