BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TargetCool

    DI: 08800073100049 · Model: RM-DC04U · RecensMedical, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TargetCool
    Primary DI
    08800073100049
    Version / Model
    RM-DC04U
    Company Name
    RecensMedical, Inc.
    Labeler DUNS
    694808508
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-11-29
    Public Version
    3
    Public Version Date
    2024-01-10
    Public Version Status
    Update
    Public Device Record Key
    e713d4b2-f8ed-4600-894a-22a8b96423a9

    Device Description

    TargetCool™ is a handheld device that can deliver rapid, precise, and controlled cooling to the skin tissue.

    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
    Yes
    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
    Yes

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEH Unit, Cryosurgical, Accessories
    MLY Vapocoolant Device

    GMDN Terms

    Code Name
    11067 General cryosurgical system, cryogen gas, mechanical

    Identifiers

    Type ID
    Primary 08800073100049