BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Epredia

    DI: 00673693089005 · Model: Paraffin, Type 3 · 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
    00673693089005
    Version / Model
    Paraffin, Type 3
    Catalog Number
    8335
    Company Name
    RICHARD-ALLAN SCIENTIFIC COMPANY
    Labeler DUNS
    929504710
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-08-07
    Public Version
    1
    Public Version Date
    2024-08-15
    Public Version Status
    New
    Public Device Record Key
    bdfab864-8636-4c0a-8d22-3dcf2953f3f5

    Device Description

    The Paraffin line is specially designed for tissue processing and embedding of histological and cytological specimens. The product is a white solid at room temperature and a clear, liquid when molten. The paraffin can be used with both open and closed tissue processors. It is also compatible with all embedding centers and manual embedding techniques. Paraffin is used in tissue processing during the infiltration steps. Melting points and polymer content differ between formulations. Choosing which type of paraffin may depend on the tissue density or personal preference of the histotechnician. Softer kinds of paraffin with less polymer tend to infiltrate tissue slightly quicker during processing but yield a softer block during embedding. Softer kinds of paraffin better lend themselves to thicker sections during microtomy. Harder kinds of paraffin with a higher polymer content usually take a little more time to infiltrate the tissue during processing but yield harder blocks that allow thinner sectioning during microtomy. Harder tissue specimens are better supported with a harder paraffin block.

    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
    KEO Formulations, Paraffin, All

    GMDN Terms

    Code Name
    57738 Paraffin-based embedding medium IVD

    Identifiers

    Type ID
    Primary 00673693089005