DEVICE: Epredia (00673693219372)

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Device Record History
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Device Identifier (DI) Information
Epredia
Xylene Substitute
In Commercial Distribution
1900231
RICHARD-ALLAN SCIENTIFIC COMPANY
00673693219372
GS1

1
929504710 *Terms of Use
Xylene Substitute Mountant was specially formulated for its compatibility with Epredia™ Xylene Substitute, but it will work very well in all routine mounting of specimens with xylene. Although compatible with Xylene Substitute, this mounting medium is not soluble in it. See the section on “Removing A Coverslip” on Instructions for Use.
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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?
43550 Microscopy mounting medium IVD
A substance intended to be used to create a seal between a microscope slide, clinical specimen and/or coverslip, to preserve the specimen and/or the integrity of any dye(s) used for staining, and enhance image quality during microscopic examination.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LEB Mounting Media
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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

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Size Type Text
No Device Sizes
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Device Record Status
25920cea-e0c1-41b0-834d-1f18458685ab
August 07, 2024
1
July 30, 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
No Package DIs found
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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)

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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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