BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Mycobacti-Loops

    DI: 00848838082757 · Model: R4609440 · REMEL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Mycobacti-Loops
    Primary DI
    00848838082757
    Version / Model
    R4609440
    Catalog Number
    R4609440
    Company Name
    REMEL, INC.
    Labeler DUNS
    065769564
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-23
    Public Version
    1
    Public Version Date
    2023-01-02
    Public Version Status
    New
    Public Device Record Key
    de2b4e34-4aef-4a4e-85f8-d99b6e071d4c

    Device Description

    M. racemosus ATCC 42647 PK/5

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JTR Kit, Quality Control For Culture Media

    GMDN Terms

    Code Name
    33365 Culture medium control

    Identifiers

    Type ID
    Primary 00848838082757