DEVICE: Epredia (00673693228299)

Device Identifier (DI) Information

Epredia
Rapid-Fixx™
In Commercial Distribution
6764212
RICHARD-ALLAN SCIENTIFIC COMPANY
00673693228299
GS1

1
929504710 *Terms of Use
Rapid-Fixx™ is a uniquely formulated, formaldehyde-base fixative recommended for frozen sections.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

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?
57744 Frozen tissue fixative IVD
A solution intended to be used as a fixative in the processing of frozen tissue sections derived from biological tissues or clinical specimens, for subsequent in vitro diagnostic analysis.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LDZ Fixative, Alcohol Containing
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FDA Premarket Submission

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

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

158d2c18-a7b1-4135-a31a-2630f647d38a
September 12, 2024
1
September 04, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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