BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Exact Osteotomy System

    DI: B562OGSCA550 · Model: OGS-CA55 · Wishbone Medical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Exact Osteotomy System
    Primary DI
    B562OGSCA550
    Version / Model
    OGS-CA55
    Company Name
    Wishbone Medical, Inc.
    Labeler DUNS
    062355158
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-09-16
    Public Version
    3
    Public Version Date
    2023-04-03
    Public Version Status
    Update
    Public Device Record Key
    c1ae0f4a-cced-4bd5-afb1-ae22f0a37db1
    Distribution End Date
    2023-03-16

    Device Description

    EXACT OSTEOTOMY SYSTEM - CHEVRON/AUSTIN (55 DEGREE)

    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
    Yes
    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
    FZX Guide, Surgical, Instrument

    GMDN Terms

    Code Name
    65079 Osteotomy guide, single-use

    Identifiers

    Type ID
    Primary B562OGSCA550