BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Prostate Procedure Probe Pack

    DI: 00810563020939 · Model: DP35-0595-108 · VARIAN MEDICAL SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Prostate Procedure Probe Pack
    Primary DI
    00810563020939
    Version / Model
    DP35-0595-108
    Catalog Number
    CRYO-207-V
    Company Name
    VARIAN MEDICAL SYSTEMS, INC.
    Labeler DUNS
    009120817
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-02-18
    Public Version
    1
    Public Version Date
    2022-02-28
    Public Version Status
    New
    Public Device Record Key
    f6919728-d123-450f-b610-7d11b95a457c

    Device Description

    Prostate Procedure Kit containing CVA2400 (6ea), CRYO-55-F (6 ea), CRYO-77 ( 1 ea)

    Device Characteristics

    Single Use
    Yes
    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEH UNIT, CRYOSURGICAL, ACCESSORIES

    GMDN Terms

    Code Name
    45150 Ophthalmic surgical procedure kit, non-medicated, single-use

    Identifiers

    Type ID
    Primary 00810563020939

    Premarket Submissions

    Submission Number Supplement Number
    K153489 000