BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Epredia

    DI: 00673693228350 · Model: Glyo-Fixx™ · 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
    00673693228350
    Version / Model
    Glyo-Fixx™
    Catalog Number
    6764262
    Company Name
    RICHARD-ALLAN SCIENTIFIC COMPANY
    Labeler DUNS
    929504710
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-07-25
    Public Version
    1
    Public Version Date
    2024-08-02
    Public Version Status
    New
    Public Device Record Key
    9882c64b-e81b-4035-9b20-7a5b3819786c

    Device Description

    Glyo-Fixx is formulated for use as a histological fixative, to replace formalin and zinc formalin for routine specimens as well as those intended for immunohistochemical or special staining procedures. It is also effective as a secondary fixative after unbuffered or buffered formalin or zinc formalin.

    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
    IFL Polyethylene Glycol Preservative

    GMDN Terms

    Code Name
    57756 Formalin substitute solution IVD

    Identifiers

    Type ID
    Primary 00673693228350