BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PULLUP TEX CLIP

    DI: 03760154008945 · Model: Adjustable fixation system for ligament reconstruction – loop only · S.B.M
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PULLUP TEX CLIP
    Primary DI
    03760154008945
    Version / Model
    Adjustable fixation system for ligament reconstruction – loop only
    Catalog Number
    PULL00LOOP
    Company Name
    S.B.M
    Labeler DUNS
    772462123
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-12-20
    Public Version
    1
    Public Version Date
    2023-12-28
    Public Version Status
    New
    Public Device Record Key
    bdda2324-ceaa-4781-9407-3653441e0184

    Device Description

    The PULLUP® TEX CLIP consists of an adjustable nonabsorbable braided loop to be used for ACL reconstruction. The device is supplied sterile, ready to use.

    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
    MBI Fastener, Fixation, Nondegradable, Soft Tissue

    GMDN Terms

    Code Name
    45062 Tendon/ligament bone anchor, non-bioabsorbable

    Identifiers

    Type ID
    Primary 03760154008945

    Premarket Submissions

    Submission Number Supplement Number
    K202193 000