BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Aura Elite

    DI: 10858711006463 · Model: DDS-503 · AMERICAN MEDICAL & DENTAL SUPPLIES INC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    100

    Basic Information

    Brand Name
    Aura Elite
    Primary DI
    10858711006463
    Version / Model
    DDS-503
    Catalog Number
    DDS-503
    Company Name
    AMERICAN MEDICAL & DENTAL SUPPLIES INC
    Labeler DUNS
    018638145
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2023-01-19
    Public Version
    1
    Public Version Date
    2023-01-27
    Public Version Status
    New
    Public Device Record Key
    cf1bf24d-b79a-48f2-9b12-2ad30b7d02db

    Device Description

    Aura Elite DDS-503-20 Size Medium - Box

    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
    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
    LZA Polymer Patient Examination Glove
    LZC Patient Examination Glove, Specialty

    GMDN Terms

    Code Name
    56286 Nitrile examination/treatment glove, non-powdered, non-antimicrobial

    Identifiers

    Type ID
    Unit of Use 00858711006565
    Primary 10858711006463