BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GraftTech

    DI: 03760154006194 · Model: Complete GraftTech instrumentation set · S.B.M
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GraftTech
    Primary DI
    03760154006194
    Version / Model
    Complete GraftTech instrumentation set
    Catalog Number
    PULLTAB000
    Company Name
    S.B.M
    Labeler DUNS
    772462123
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-06-12
    Public Version
    1
    Public Version Date
    2024-06-20
    Public Version Status
    New
    Public Device Record Key
    6577903d-4059-4071-a833-45edb5e00b45

    Device Description

    Complete graft preparation station set intended to be used to prepare the graft + PULLUP construct for arthroscopic reconstruction of the ACL.

    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
    Yes
    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
    LXH Orthopedic Manual Surgical Instrument

    GMDN Terms

    Code Name
    44091 Arthroscopic surgical procedure kit, non-medicated, reusable

    Identifiers

    Type ID
    Primary 03760154006194