| Primary Device ID | 04946433600515 |
| NIH Device Record Key | e5281e2f-e635-4717-aaab-34656ffb863c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tissue-Tek® TEC™ 6 |
| Version Model Number | 5109 |
| Catalog Number | 5109 |
| 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 | true |
| Manufacturing Date | true |
| 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 | |
| Phone | +1(310)972-7800 |
| TS@sakuraus.com | |
| Phone | +1(310)972-7800 |
| TS@sakuraus.com | |
| Phone | +1(310)972-7800 |
| TS@sakuraus.com | |
| Phone | +1(310)972-7800 |
| TS@sakuraus.com | |
| Phone | +1(310)972-7800 |
| TS@sakuraus.com | |
| Phone | +1(310)972-7800 |
| TS@sakuraus.com | |
| Phone | +1(310)972-7800 |
| TS@sakuraus.com | |
| Phone | +1(310)972-7800 |
| TS@sakuraus.com | |
| Phone | +1(310)972-7800 |
| TS@sakuraus.com | |
| Phone | +1(310)972-7800 |
| TS@sakuraus.com | |
| Phone | +1(310)972-7800 |
| TS@sakuraus.com | |
| Phone | +1(310)972-7800 |
| TS@sakuraus.com | |
| Phone | +1(310)972-7800 |
| TS@sakuraus.com | |
| Phone | +1(310)972-7800 |
| TS@sakuraus.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04946433600515 [Primary] |
| IDW | DISPENSERS, PARAFFIN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-14 |
| Device Publish Date | 2020-05-06 |
| 00615233079640 | Foot Pedal Switch |
| 00615233079626 | 75-Cassette Transfer Tray |
| 00615233079459 | Plus Cryo Console |
| 04946433600515 | Cryo Module (Requires connnection to product code 5108 for operation) |
| 04946433600508 | Embedding Module |
| 04946433600492 | Plus Cryo Console |
| 00615233009746 | Embedding Console System |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TISSUE-TEK 72084436 0743380 Live/Registered |
LAB-TEK PLASTICS CO. 1959-11-02 |