BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Kryo

    DI: B199GDMR75000 · Model: MR7-500 · PLANER LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Kryo
    Primary DI
    B199GDMR75000
    Version / Model
    MR7-500
    Catalog Number
    GDMR7-500
    Company Name
    PLANER LIMITED
    Labeler DUNS
    217190495
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-04-30
    Public Version
    1
    Public Version Date
    2023-05-08
    Public Version Status
    New
    Public Device Record Key
    53b6a9b3-b032-4a25-b173-8bf3d329a4c7

    Device Description

    MR7 Controller for Kryo 560 & 570 Freezers

    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
    Yes
    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
    KSP Apparatus, Cell-Freezing And Reagents

    GMDN Terms

    Code Name
    35829 Freezer control unit, programmable

    Identifiers

    Type ID
    Primary B199GDMR75000