BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Setmark Incorporated

    DI: 00854204008047 · Model: TR-136 · SETMARK INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Setmark Incorporated
    Primary DI
    00854204008047
    Version / Model
    TR-136
    Company Name
    SETMARK INC.
    Labeler DUNS
    080798558
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-01-31
    Public Version
    3
    Public Version Date
    2018-10-05
    Public Version Status
    Update
    Public Device Record Key
    e1c1da7c-da9e-4605-a677-5a0db3ab909d

    Device Description

    Bariatric Walker: adj height: 32" - 38-1/2"

    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
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ITJ Walker, Mechanical

    GMDN Terms

    Code Name
    37952 Bariatric walker, foldable

    Identifiers

    Type ID
    Primary 00854204008047