| Primary Device ID | 09421904065802 |
| NIH Device Record Key | 1c9b30c9-b45d-4a0a-8812-f7945646dc21 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OviTex LPR Reinforced Bioscaffold |
| Version Model Number | F10244-1523L |
| Catalog Number | F10244-1523L |
| 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 | false |
| 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 |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Length | 18 Centimeter |
| Width | 23 Centimeter |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09421904065802 [Primary] |
| FTM | Mesh, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-10-21 |
| Device Publish Date | 2018-10-26 |
| 09421905067539 | OviTex™ Reinforced BioScaffold with Permanent Polymer (OviTex) is a sterile bioscaffold compos |
| 09421904065802 | OviTex™ Reinforced BioScaffold with Permanent Polymer (OviTex) is a sterile bioscaffold compos |
| 09421904065796 | OviTex™ Reinforced BioScaffold with Permanent Polymer (OviTex) is a sterile bioscaffold compos |
| 09421904065789 | OviTex™ Reinforced BioScaffold with Permanent Polymer (OviTex) is a sterile bioscaffold compos |
| 09421904065772 | OviTex™ Reinforced BioScaffold with Permanent Polymer (OviTex) is a sterile bioscaffold compos |
| 09421904065765 | OviTex™ Reinforced BioScaffold with Permanent Polymer (OviTex) is a sterile bioscaffold compos |
| 09421906661569 | OviTex™ Reinforced Tissue Matrix with Permanent Polymer (OviTex) is a sterile bioscaffold comp |
| 09421906661552 | OviTex™ Reinforced Tissue Matrix with Permanent Polymer (OviTex) is a sterile bioscaffold comp |