DEVICE: Epredia (00673693235945)

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Device Record History
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Device Identifier (DI) Information
Epredia
Immu-Mount™
In Commercial Distribution
9990414
RICHARD-ALLAN SCIENTIFIC COMPANY
00673693235945
GS1

1
929504710 *Terms of Use
Immu-Mount™ and Aqua-Mount™ are water-based mounting media specially formulated for use with frozen section, immunoperoxidase techniques, and immunofluorescent preparations.
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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

[?]
Size Type Text
No Device Sizes
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Device Record Status
f7a6a96e-f623-4d47-9b82-d7bed275b2b3
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

[?]
No Customer Contact currently defined
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