Primary Device ID | 00615233081476 |
NIH Device Record Key | b920cb2b-a2b5-446e-b05c-d902b81ca6bd |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Tissue-Tek Xpress® |
Version Model Number | 7109 |
Catalog Number | 7109 |
Company DUNS | 179135769 |
Company Name | SAKURA FINETEK U.S.A., INC. |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | +1(310)972-7800 |
TS@sakuraus.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00615233081476 [Primary] |
IEO | PROCESSOR, TISSUE, AUTOMATED |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-03-02 |
Device Publish Date | 2020-02-23 |
10615233081510 | Molecular Fixative |
10615233081503 | Pre-Processing Fixative |
10615233081497 | Pre-Processing Solution |
00615233081568 | Processing Reagent Set, Formula 3 |
00615233081483 | Processing Reagent Set, Formula 1 |
00615233081704 | x50 Rapid Tissue Processor |
00615233081629 | x120 Rapid Tissue Processor |
00615233081476 | Basket Transportation Tray |
04946433600553 | x120 Rapid Tissue Processor |
04946433600249 | x50 Rapid Tissue Processor |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TISSUE-TEK XPRESS 78266653 2929777 Live/Registered |
Sakura Finetek, U.S.A., Inc. 2003-06-24 |