DEVICE: Epredia (00673693556064)

Device Identifier (DI) Information

Epredia
Fast Flex™ Holding Solution 5 L
In Commercial Distribution
9800-1
RICHARD-ALLAN SCIENTIFIC COMPANY
00673693556064
GS1

1
929504710 *Terms of Use
The Fast Flex Tissue Processing System was designed to accommodate a wide range of tissue processing demands. These reagents, when used together with the STP 420ES or Pathcentre tissue processors, will significantly reduce tissue processing times and produce very high-quality results. The Fast Flex Tissue Processing System provides optimal tissue processing and staining results based on the patented rotational technology in the main chamber of the STP 420ES and the chemically enhanced Fast Flex reagents. The Fast Flex Tissue Processing System also produces excellent tissue and staining results when used with the Pathcentre tissue processor. Tissue/chemical interactions, reactions, and diffusion rates are accelerated, and depending upon tissue thickness, fatty tissue such as breast, bowel, and lymph node process very efficiently within this system. Our experience has additionally shown that bloody tissues also process well, especially when Holding Solution is utilized in the grossing room. Traditional hematoxylin and eosin staining demonstrates well-delineated nuclear chromatin, as well as superb cytoplasmic contrast.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
Yes
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
63938 Histology tissue processing reagent kit IVD
A collection of reagents intended to be used for tissue processing in a histology laboratory to prepare biological tissues or clinical tissue specimens for embedding, or related procedures, by successively removing water and alcohol. It may consist of a fixative (e.g., formalin), a dehydrating agent (e.g., alcohol) and a clearing reagent (e.g., xylene).
Active false
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FDA Product Code

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Product Code Product Code Name
PPM General Purpose Reagent
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

369a5983-63da-492e-9c94-e84a945826b8
August 01, 2024
1
July 24, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
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None
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Production Identifier(s) in UDI

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Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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