BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    WishBone K-Wire System

    DI: B56213904001620S10 · Model: 13-904-001620S-1 · Wishbone Medical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    WishBone K-Wire System
    Primary DI
    B56213904001620S10
    Version / Model
    13-904-001620S-1
    Catalog Number
    13-904-001620S-1
    Company Name
    Wishbone Medical, Inc.
    Labeler DUNS
    062355158
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-07-18
    Public Version
    4
    Public Version Date
    2024-01-03
    Public Version Status
    Update
    Public Device Record Key
    8a1ad209-e691-4f64-9a10-fa8647b2d3d3

    Device Description

    1.60mm x 200mm K-wire

    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
    HTY Pin, Fixation, Smooth

    GMDN Terms

    Code Name
    46651 Spinal bone screw, non-bioabsorbable

    Identifiers

    Type ID
    Primary B56213904001620S10

    Premarket Submissions

    Submission Number Supplement Number
    K173013 000