| Primary Device ID | 00615233011008 | 
| NIH Device Record Key | 22601b51-499f-4506-8017-9bafdb8f62c2 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Tissue-Tek Prisma® | 
| Version Model Number | 4900 | 
| 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 | true | 
| Serial Number | false | 
| Manufacturing Date | true | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Phone | 310-972-7800 | 
| TS@sakuraus.com | |
| Phone | 310-972-7800 | 
| TS@sakuraus.com | |
| Phone | 310-972-7800 | 
| TS@sakuraus.com | |
| Phone | 310-972-7800 | 
| TS@sakuraus.com | |
| Phone | 310-972-7800 | 
| TS@sakuraus.com | |
| Phone | 310-972-7800 | 
| TS@sakuraus.com | |
| Phone | 310-972-7800 | 
| TS@sakuraus.com | |
| Phone | 310-972-7800 | 
| TS@sakuraus.com | |
| Phone | 310-972-7800 | 
| TS@sakuraus.com | |
| Phone | 310-972-7800 | 
| TS@sakuraus.com | |
| Phone | 310-972-7800 | 
| TS@sakuraus.com | |
| Phone | 310-972-7800 | 
| TS@sakuraus.com | |
| Phone | 310-972-7800 | 
| TS@sakuraus.com | |
| Phone | 310-972-7800 | 
| TS@sakuraus.com | |
| Phone | 310-972-7800 | 
| TS@sakuraus.com | |
| Phone | 310-972-7800 | 
| TS@sakuraus.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00615233011008 [Primary] | 
| HZT | Reagent, Schiff | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2024-10-21 | 
| Device Publish Date | 2024-10-11 | 
| 00615233000040 | H&E Stain Kit #1 | 
| 00615233080585 | Tissue-Tek Prisma® Link Between Tissue-Tek Prisma® and Tissue-Tek® Glas™ g2 | 
| 00615233080332 | Link System Kit for Tissue-Tek Film® Coverslipper | 
| 00615233011008 | H&E Stain Kit #2 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  TISSUE-TEK PRISMA  78530890  3131057 Live/Registered | Sakura Finetek U.S.A., Inc. 2004-12-10 |