DEVICE: NA (00848838023743)

Device Identifier (DI) Information

NA
R21502
In Commercial Distribution

REMEL, INC.
00848838023743
GS1

50
065769564 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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?
42690 Acridine orange solution IVD
An acridine orange solution/stain intended to be used alone, or in combination with other solutions/stains, for the visualization of biological/clinical specimen tissue structures and/or intra/extracellular elements.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
JFO Fluorometric, Calcium
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K920974 000
No 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

ba632175-c380-4510-98f9-7862af6c01bc
July 06, 2018
3
September 24, 2016
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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: 00848838099830 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
8002556730
ITechnicalSupport@remel.com
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