BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CATAMARAN™ SIJ Fusion System

    DI: 00850033676235 · Model: 40327 · TENON MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CATAMARAN™ SIJ Fusion System
    Primary DI
    00850033676235
    Version / Model
    40327
    Catalog Number
    40327
    Company Name
    TENON MEDICAL, INC.
    Labeler DUNS
    117014636
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-12-17
    Public Version
    2
    Public Version Date
    2022-03-15
    Public Version Status
    Update
    Public Device Record Key
    1cca141d-a060-4283-bd8f-ff9b6cfb076a

    Device Description

    Drill Bit 10mmx40mm, Catamaran

    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
    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

    GMDN Terms

    Code Name
    62399 Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile

    Identifiers

    Type ID
    Primary 00850033676235

    Premarket Submissions

    Submission Number Supplement Number
    K180818 000