| Primary Device ID | 09421906661910 |
| NIH Device Record Key | c8db9492-4ebd-4990-8462-31adef902718 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OviTex IHR Reinforced Bioscaffold with Permanent Polymer (bean) |
| Version Model Number | F10243-1317I |
| Catalog Number | F10243-1317I |
| Company DUNS | 594540572 |
| Company Name | AROA BIOSURGERY LIMITED |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Width | 17 Centimeter |
| Length | 13 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09421906661910 [Primary] |
| FTL | Mesh, Surgical, Polymeric |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-29 |
| Device Publish Date | 2024-03-21 |
| 09421906661927 | Ovitex IHR is a surgical mesh device intended to provide structural and mechanical support for s |
| 09421906661910 | Ovitex IHR is a surgical mesh device intended to provide structural and mechanical support for s |
| 09421906661903 | Ovitex IHR is a surgical mesh device intended to provide structural and mechanical support for s |