BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CorPath GRX Cassette

    DI: 00816280023055 · Model: 305 · Corindus, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    4

    Basic Information

    Brand Name
    CorPath GRX Cassette
    Primary DI
    00816280023055
    Version / Model
    305
    Catalog Number
    305
    Company Name
    Corindus, Inc.
    Labeler DUNS
    781746586
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    4
    Record Status
    Published
    Publish Date
    2017-01-20
    Public Version
    8
    Public Version Date
    2022-10-19
    Public Version Status
    Update
    Public Device Record Key
    21f8371a-b095-4ce6-bec7-fe5d2adc4ba2

    Device Characteristics

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

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DXX System, Catheter Control, Steerable

    GMDN Terms

    Code Name
    31742 Cardiac mapping system workstation

    Identifiers

    Type ID
    Primary 00816280023055
    Unit of Use 00816280023048

    Customer Contacts

    Phone
    +1-800-888-7436
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K160121 000
    K173288 000
    K202275 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    10 – 30 Degrees Celsius