BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Non-Surgical Isolation Gowns

    DI: 00723896018057 · Model: IL-2030WTU · PRACTICON, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Non-Surgical Isolation Gowns
    Primary DI
    00723896018057
    Version / Model
    IL-2030WTU
    Catalog Number
    7146811
    Company Name
    PRACTICON, INC.
    Labeler DUNS
    119193803
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-08
    Public Version
    1
    Public Version Date
    2023-06-16
    Public Version Status
    New
    Public Device Record Key
    dd16e002-da83-4f2f-a905-68f20c24893b

    Device Description

    Four layer SMMS fabric isolation gown. Level 2 fluid resistance. Closed front from neck to knees, pullover, tear away neck style. Chest pocket and Thumb-loop cuffs. White. 10 per bag.

    Device Characteristics

    Single Use
    Yes
    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
    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
    OEA Non-Surgical Isolation Gown

    GMDN Terms

    Code Name
    35492 Isolation gown, single-use

    Identifiers

    Type ID
    Package 00723896018064
    Primary 00723896018057