BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PMI

    DI: 00812608020256 · Model: PMISG12B2 · PROGRESSIVE MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PMI
    Primary DI
    00812608020256
    Version / Model
    PMISG12B2
    Catalog Number
    PMISG12B2
    Company Name
    PROGRESSIVE MEDICAL, INC.
    Labeler DUNS
    192135242
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    5
    Public Version Date
    2022-06-17
    Public Version Status
    Update
    Public Device Record Key
    1807dedb-fd2d-4736-bcd5-7ba178979ffd

    Device Description

    PMI Suture Guide Bariatric Length (12mm - 2 Holes) - Reusable

    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
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Moist Heat or Steam Sterilization", "Ethylene Oxide"]

    Product Codes

    Code Name
    FZX Guide, Surgical, Instrument

    GMDN Terms

    Code Name
    60734 Needle guide, reusable

    Identifiers

    Type ID
    Package 10812608020253
    Primary 00812608020256