| Primary Device ID | 00812593021726 |
| NIH Device Record Key | 72abdf22-b5cd-4ac1-ada4-e092d58e4c26 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | bYomed Surgical MatriX |
| Version Model Number | BYO-030 |
| 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 | 00812593021726 [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 | 2024-11-13 |
| Device Publish Date | 2024-11-05 |
| 00812593022020 - Accelagen Surgical Collagen Matrix | 2025-05-30 Accelagen Surgical Collagen Matrix 2mL |
| 00812593022037 - Agilon Surgical Matrix | 2025-05-30 Agilon Surgical Matrix 2mL |
| 00812593022013 - MicroStat Collagen Matrix | 2025-05-16 MicroStat Collagen Matrix |
| 00812593022006 - ColSyntek | 2025-05-06 ColSyntek Collagen Matrix |
| 00812593021993 - Accelagen Surgical Collagen Matrix | 2025-03-05 Accelagen Surgical Collagen Matrix |
| 00812593021931 - Summit Moldable | 2025-03-03 Summit Moldable 1cc |
| 00812593021948 - Summit Moldable | 2025-03-03 Summit Moldable 2.5cc |
| 00812593021955 - Summit Moldable | 2025-03-03 Summit Moldable 5cc |