BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ExoShape Teno

    DI: M97011000108200 · Model: 1100-01-0820 · Medshape, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ExoShape Teno
    Primary DI
    M97011000108200
    Version / Model
    1100-01-0820
    Company Name
    Medshape, Inc.
    Labeler DUNS
    601306413
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-05-19
    Public Version
    5
    Public Version Date
    2019-03-21
    Public Version Status
    Update
    Public Device Record Key
    adeb0770-b465-44d0-85ef-be41d18780f1

    Device Description

    EXOSHAPE-TENO Deployment Cartridge, 8mm x 20mm, Flat-Back

    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
    MR Safe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    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
    HWC Screw, Fixation, Bone

    GMDN Terms

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

    Identifiers

    Type ID
    Primary M97011000108200

    Premarket Submissions

    Submission Number Supplement Number
    K101808 000