BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AuraPrene

    DI: 00858711006350 · Model: DDS-305 · AMERICAN MEDICAL & DENTAL SUPPLIES INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AuraPrene
    Primary DI
    00858711006350
    Version / Model
    DDS-305
    Catalog Number
    DDS-305
    Company Name
    AMERICAN MEDICAL & DENTAL SUPPLIES INC
    Labeler DUNS
    018638145
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-02-01
    Public Version
    2
    Public Version Date
    2023-05-03
    Public Version Status
    Update
    Public Device Record Key
    1eea52c5-7f7d-4743-b385-f311271937be

    Device Description

    AuraPrene DDS-305 Size X-Large Inner Pack - 100

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LZA Polymer Patient Examination Glove

    GMDN Terms

    Code Name
    56288 Polychloroprene examination/treatment glove, non-powdered

    Identifiers

    Type ID
    Primary 00858711006350