| Primary Device ID | 00816085022437 |
| NIH Device Record Key | a02dc73f-3798-4a14-8b34-f3010870f0bf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PVA (Zn) Fix/10% Formalin 25 sets |
| Version Model Number | 1 |
| Catalog Number | 0003102 |
| Company DUNS | 103105524 |
| Company Name | Alpha-TEC Systems, Inc. |
| Device Count | 25 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816085022314 [Primary] |
| GS1 | 00816085022437 [Unit of Use] |
| LDZ | Fixative, Alcohol Containing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-28 |
| Device Publish Date | 2022-07-20 |
| 00816085020075 - Alpha-Tec Systems | 2022-08-19 CELL-BOND Slides, 2 wells [15mm], red background |
| 00816085020105 - Alpha-Tec Systems | 2022-08-19 CELL-BOND Slide, 1 Red well, no background |
| 00816085020273 - Alpha-Tec Systems | 2022-08-19 NAC-PAC N30 Tray |
| 00816085020334 - Alpha-Tec Systems | 2022-08-19 CELL-BOND Slides, 1 well, black background |
| 00816085020167 - Alpha-Tec Systems | 2022-08-19 Nocardia Stain Control Slides |
| 00816085020655 - Alpha-Tec Systems | 2022-08-19 70% Ethanol |
| 00816085020877 - Alpha-Tec Systems | 2022-08-19 NALC tablets 1x10ea |
| 00816085020884 - Alpha-Tec Systems | 2022-08-19 .25g Cysteine |