BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ComPel MLR Surgical Gown

    DI: 00634916797152 · Model: 75674915 · STANDARD TEXTILE CO., INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    24

    Basic Information

    Brand Name
    ComPel MLR Surgical Gown
    Primary DI
    00634916797152
    Version / Model
    75674915
    Company Name
    STANDARD TEXTILE CO., INC.
    Labeler DUNS
    006999858
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    24
    Record Status
    Published
    Publish Date
    2021-06-09
    Public Version
    1
    Public Version Date
    2021-06-17
    Public Version Status
    New
    Public Device Record Key
    1cb2579b-3977-4c90-b5e7-f75467d7783f

    Device Description

    Surgical GWN MLR CMPL 2-Ply Front/Sleeves Aqua Compel MLR and White Compel MLR w/Negastat, 1-Ply Aqua MLR Comfort Panel Backs, Large

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    FYA Gown, Surgical

    GMDN Terms

    Code Name
    11902 Surgical gown, reusable

    Identifiers

    Type ID
    Unit of Use 10634916797159
    Primary 00634916797152

    Customer Contacts

    Phone
    1-800-999-0400
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K041541 000