BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SAMBA SCREW SYSTEM

    DI: M364111109FD720 · Model: 11-1109-FD7-2 · MEDICAL DESIGNS LLC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SAMBA SCREW SYSTEM
    Primary DI
    M364111109FD720
    Version / Model
    11-1109-FD7-2
    Company Name
    MEDICAL DESIGNS LLC
    Labeler DUNS
    003815548
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-27
    Public Version
    5
    Public Version Date
    2022-11-28
    Public Version Status
    Update
    Public Device Record Key
    ad6b6ad0-6eec-4568-8a54-d5b224088994

    Device Description

    Parallel Guide Locking Nut

    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
    No
    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
    OUR Sacroiliac Joint Fixation
    HWC Screw, Fixation, Bone

    GMDN Terms

    Code Name
    58849 Sacroiliac joint transarticular fixation/arthrodesis implantation kit

    Identifiers

    Type ID
    Direct Marking 11110972
    Primary M364111109FD720

    Premarket Submissions

    Submission Number Supplement Number
    K121148 000