BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Epredia

    DI: 00673693473972 · Model: Ice-It™ · RICHARD-ALLAN SCIENTIFIC COMPANY
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Epredia
    Primary DI
    00673693473972
    Version / Model
    Ice-It™
    Catalog Number
    8325
    Company Name
    RICHARD-ALLAN SCIENTIFIC COMPANY
    Labeler DUNS
    929504710
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-08-02
    Public Version
    1
    Public Version Date
    2024-08-12
    Public Version Status
    New
    Public Device Record Key
    662635ff-5c8c-4e80-92a2-fc4f532f325a

    Device Description

    Cytocool™ II and Ice-It™ are intended for use in histology laboratories for rapid freezing of tissue specimens. Cytocool™ II and Ice-It™ have a boiling point of -26.5° C/-15.1° F, which indicates fast freezing. These products do not cause ozone depletion and significantly reduce global warming potential. These products contain tetrafluoroethane.

    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
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LEA Preservative, Cytological

    GMDN Terms

    Code Name
    57739 Tissue freezing/embedding medium IVD

    Identifiers

    Type ID
    Primary 00673693473972