| Primary Device ID | 00615233078896 |
| NIH Device Record Key | b59f6dc5-65d1-4e31-bfbe-f335afe6aa1d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tissue-Tek® SCA™ |
| Version Model Number | 4772 |
| Catalog Number | 4772 |
| 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 | 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 |
| [email protected] |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00615233078896 [Primary] |
| KEW | SLIDES, MICROSCOPE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-25 |
| Device Publish Date | 2020-03-17 |
| 00615233082367 - VisionTek® | 2020-03-25 Slide Carrier |
| 00615233081834 - Tissue-Tek® Quick-Ray™ | 2020-03-25 Recipient Base Mold; 3/case |
| 00615233081827 - Tissue-Tek® Quick-Ray™ | 2020-03-25 Recipient Block, 5 mm |
| 00615233081810 - Tissue-Tek® Quick-Ray™ | 2020-03-25 Recipient Block, 3 mm |
| 00615233081803 - Tissue-Tek® Quick-Ray™ | 2020-03-25 Recipient Block, 2 mm |
| 00615233081797 - Tissue-Tek® Quick-Ray™ | 2020-03-25 Recipient Block, 1 mm |
| 00615233081735 - Tissue-Tek® Quick-Ray™ | 2020-03-25 Tissue Microarray System |
| 00615233080837 - Tissue-Tek® | 2020-03-25 Barcode Reader System for Coverslippers |