BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Alleset

    DI: 16931918186016 · Model: Model 92-2030-S2 · GRI Medical & Electronic Technology Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Alleset
    Primary DI
    16931918186016
    Version / Model
    Model 92-2030-S2
    Company Name
    GRI Medical & Electronic Technology Co., Ltd.
    Labeler DUNS
    679894738
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-04-22
    Public Version
    2
    Public Version Date
    2021-12-27
    Public Version Status
    Update
    Public Device Record Key
    eed10c41-dd4e-4073-93ab-61b0ead9d51f

    Device Description

    Gown_Set-In sleeve_Standard_X-Large_W/ two hand towels_Sterile_22ea/cs

    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    FYA GOWN, SURGICAL

    GMDN Terms

    Code Name
    35091 Surgical gown, single-use

    Identifiers

    Type ID
    Package 26931918186013
    Primary 16931918186016

    Customer Contacts

    Phone
    +86057383617385
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K102652 000