BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Frigitronics

    DI: 00888937004083 · Model: 163 · Coopersurgical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Frigitronics
    Primary DI
    00888937004083
    Version / Model
    163
    Company Name
    Coopersurgical, Inc.
    Labeler DUNS
    801895244
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-07-20
    Public Version
    4
    Public Version Date
    2024-02-28
    Public Version Status
    Update
    Public Device Record Key
    1bc18428-af32-489b-a081-e07d7d835c40

    Device Description

    Supercool Retinal, Spherical Probe. Tip Sphere: 3.0mm diameter. Shaft: 28mm length x 2.1mm diameter.

    Device Characteristics

    Single Use
    No
    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
    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
    Yes
    Sterilization Methods
    ["Ethylene Oxide", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    HQA Unit, Cryotherapy, Ophthalmic

    GMDN Terms

    Code Name
    43612 Ophthalmic cryosurgical system applicator, retinal

    Identifiers

    Type ID
    Primary 00888937004083