BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Medegen Medical products

    DI: H362999112 · Model: 99911 · MEDEGEN MEDICAL PRODUCTS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

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    Basic Information

    Brand Name
    Medegen Medical products
    Primary DI
    H362999112
    Version / Model
    99911
    Catalog Number
    99911
    Company Name
    MEDEGEN MEDICAL PRODUCTS, LLC
    Labeler DUNS
    055527753
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    6
    Public Version Date
    2021-04-07
    Public Version Status
    Update
    Public Device Record Key
    d404c139-3f17-4f89-a55b-8f5c28a886dc

    Device Description

    Gown: Impervious Yel Actifend 50/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
    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
    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
    35091 Surgical gown, single-use

    Identifiers

    Type ID
    Primary H362999112
    Unit of Use H362999110