BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Epredia

    DI: 00673693088848 · Model: Flex 100 · 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
    00673693088848
    Version / Model
    Flex 100
    Catalog Number
    8155
    Company Name
    RICHARD-ALLAN SCIENTIFIC COMPANY
    Labeler DUNS
    929504710
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-07-28
    Public Version
    1
    Public Version Date
    2024-08-05
    Public Version Status
    New
    Public Device Record Key
    0d3723d8-7929-485f-a4c7-a303a9023f83

    Device Description

    Signature Series Flex is a patented dehydrating reagent specifically designed for processing and staining of histological and cytological tissue specimens. Flex is a clear, colorless blend of isopropyl and methyl alcohol. It is a non-controlled substance and does not require record keeping. Flex is available in concentrations of 80%, 95% and 100%. It is readily miscible with water to form any desired grade of alcohol. Flex is miscible with all clearing reagents. Studies have indicated that Flex does not over-dehydrate small tissue specimens as rapidly as ethyl and isopropyl alcohol, when used in accordance with the processing guidelines developed for Flex. The absence of over-dehydration during tissue processing allows for consistent results with both large and small tissue specimens. Flex can be used in tissue processing, staining and as a dye or stain solvent in place of ethyl alcohol. Flex can be used in all special stains that require dehydration in ethyl alcohol and in immunohistochemical reactions that are compatible with alcoholic dehydrants. Flex has been proven to produce brilliant hematoxylin and eosin stains, with crisp nuclear detail when used within designated guidelines. Flex is compatible with both open and closed tissue processors. Flex is a flammable product and must be stored in a flammable fire cabinet.

    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
    PPM General Purpose Reagent

    GMDN Terms

    Code Name
    57724 Reagent grade alcohol solution IVD

    Identifiers

    Type ID
    Primary 00673693088848