BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CRYOcheck™ Platelet Lysate

    DI: 00843876000435 · Model: PNP-10 · Precision Biologic Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    25

    Basic Information

    Brand Name
    CRYOcheck™ Platelet Lysate
    Primary DI
    00843876000435
    Version / Model
    PNP-10
    Company Name
    Precision Biologic Inc
    Labeler DUNS
    244713368
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    25
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    c4f4320e-eac7-4c05-836e-c7a30fd387ff

    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
    No
    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
    GGW Test, Time, Partial Thromboplastin

    GMDN Terms

    Code Name
    56203 Lupus anticoagulant marker IVD, reagent

    Identifiers

    Type ID
    Primary 00843876000435
    Unit of Use 00843876010434

    Premarket Submissions

    Submission Number Supplement Number
    K982062 000