BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Cross Element Guide Sleeve

    DI: 00816101010370 · Model: NA · TOBY ORTHOPAEDICS
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Cross Element Guide Sleeve
    Primary DI
    00816101010370
    Version / Model
    NA
    Catalog Number
    TO-FIX-CEGS
    Company Name
    TOBY ORTHOPAEDICS
    Labeler DUNS
    024163331
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-08-28
    Public Version
    1
    Public Version Date
    2020-09-07
    Public Version Status
    New
    Public Device Record Key
    57568f34-a144-471e-b89d-e7292e9b57be

    Device Description

    Guides are stainless steel parts of various designs that allow various drill diameters. Some guides are laser weld assemblies with a handle, and others are threaded to screw into plates.

    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
    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
    GCZ Retainer, Surgical

    GMDN Terms

    Code Name
    44758 General external orthopaedic fixation system implantation kit, reusable

    Identifiers

    Type ID
    Primary 00816101010370