BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    STA R Max®

    DI: 03607450590135 · Model: 59013 · DIAGNOSTICA STAGO
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    STA R Max®
    Primary DI
    03607450590135
    Version / Model
    59013
    Company Name
    DIAGNOSTICA STAGO
    Labeler DUNS
    262277122
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-15
    Public Version
    4
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    c16c4828-7b0c-4239-8162-085c94c8c963

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JPA SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

    GMDN Terms

    Code Name
    56689 Coagulation analyser IVD, laboratory

    Identifiers

    Type ID
    Primary 03607450590135

    Premarket Submissions

    Submission Number Supplement Number
    K082675 000
    K093001 000
    K151867 000
    K983460 000