BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Precaution/Isolation Gown

    DI: 00634916013153 · Model: 6610M441 · STANDARD TEXTILE CO., INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    48

    Basic Information

    Brand Name
    Precaution/Isolation Gown
    Primary DI
    00634916013153
    Version / Model
    6610M441
    Catalog Number
    6610M441
    Company Name
    STANDARD TEXTILE CO., INC.
    Labeler DUNS
    006999858
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    48
    Record Status
    Published
    Publish Date
    2018-01-29
    Public Version
    3
    Public Version Date
    2023-06-30
    Public Version Status
    Update
    Public Device Record Key
    d3a36bac-beef-421e-b74c-5dd4cce29137
    Distribution End Date
    2021-07-27

    Device Description

    PRECAUTION GOWN PRINTCLOTH YELLOW L RM (98 6226) USE: 66102591

    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
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OEA Non-Surgical Isolation Gown

    GMDN Terms

    Code Name
    35452 Isolation gown, reusable

    Identifiers

    Type ID
    Primary 00634916013153
    Unit of Use 10634916013153

    Customer Contacts

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