BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ACU-DTM

    DI: 10814105021207 · Model: M101 · ACUDERM, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    24

    Basic Information

    Brand Name
    ACU-DTM
    Primary DI
    10814105021207
    Version / Model
    M101
    Company Name
    ACUDERM, INC.
    Labeler DUNS
    071426803
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    24
    Record Status
    Published
    Publish Date
    2020-09-22
    Public Version
    1
    Public Version Date
    2020-09-30
    Public Version Status
    New
    Public Device Record Key
    41973e76-38d1-4c38-bc48-63e932d00968

    Device Description

    ACU-DTM, Dermatophyte Test Medium, 24/bX

    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
    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
    JSJ Culture Media, Selective And Non-Differential

    GMDN Terms

    Code Name
    33358 Multiple dermatophyte species culture isolate identification IVD, kit

    Identifiers

    Type ID
    Unit of Use 00814105021200
    Primary 10814105021207