BEUDAMED
    Product Code: NDS FDA class 2 21 CFR 876.5885

    Media, Culture, Ex Vivo, Tissue And Cell

    Gastroenterology, Urology

    The Media, Culture, Ex Vivo, Tissue And Cell (product code NDS) is a specialized growth medium used to maintain and culture living tissue or cells outside of the body during ex vivo processing, such as in tissue engineering or transplantation preparation. It is an FDA Class 2 device within the Gastroenterology and Urology specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.

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    510(k)s
    9
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    7
    Years Active
    24

    Basic Information

    Product Code
    NDS
    Device Class
    FDA class 2
    Regulation Number
    876.5885
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 9 510(k) clearances via K numbers.

    K Number Device Name
    K232543 MSC SFM
    K240247 “MoFi” Cell Culture Basal Medium
    K231804 PRIME-XV FreezIS DMSO-Free MD
    K201789 CT-STOR
    K113566 OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM
    K103302 STEMPRO MSC SFM
    K100616 KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618
    K022086 AIM-V (R) MEDIUM, MODEL 087-0112
    DEN000008 DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.