| Primary Device ID | 00812593022006 |
| NIH Device Record Key | a9f406ef-75cf-4c13-b35f-069754e06dea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ColSyntek |
| Version Model Number | ZS3001-5 |
| Company DUNS | 832270370 |
| Company Name | Biogennix, LLC |
| Device Count | 1 |
| 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 | false |
| 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 | 00812593022006 [Primary] |
| KGN | Wound Dressing With Animal-Derived Material(S) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-06 |
| Device Publish Date | 2025-04-28 |
| 00812593022952 - NeoForm Matrix | 2025-09-30 NeoForm Matrix Tapered, 5cc |
| 00812593022969 - NeoForm Matrix | 2025-09-30 NeoForm Matrix Medium |
| 00812593022976 - NeoForm Matrix | 2025-09-30 NeoFor Matrix Forte, 10cc |
| 00812593022983 - NeoForm Matrix | 2025-09-30 NeoForm Matrix Tapered, 10cc |
| 00812593022990 - NeoForm Matrix | 2025-09-30 NeoForm Matrix Large |
| 00812593023003 - NeoForm Matrix | 2025-09-30 NeoForm Matrix Forte, 20cc |
| 00812593022914 - nanOss Strata Moldable | 2025-09-26 nanOss Strata Moldable 1.5cc |
| 00812593022921 - nanOss Strata Moldable | 2025-09-26 nanOss Strata Moldable 3cc |