DEVICE: Tissue-Tek® (00615233009029)
Device Identifier (DI) Information
Tissue-Tek®
6021
In Commercial Distribution
6021
SAKURA FINETEK U.S.A., INC.
6021
In Commercial Distribution
6021
SAKURA FINETEK U.S.A., INC.
Reagent Alcohol 70% v/v
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? |
---|---|---|---|---|
57724 | Reagent grade alcohol solution IVD |
A reagent grade alcohol solution (e.g., methanol, ethanol, isopropanol) intended to be used as a dehydrant in the processing of biological tissues or clinical specimens.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PPM | General purpose reagent |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
c6c12877-bacf-4c15-be18-05c0a23e5577
September 14, 2020
1
September 05, 2020
September 14, 2020
1
September 05, 2020
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00615233009012
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(310)972-7800
TS@sakuraus.com
TS@sakuraus.com