| Primary Device ID | H373FS20303 |
| NIH Device Record Key | c2af227f-8fa0-4925-a94f-4e6b2ba2836f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GORE BIO-A Tissue Reinforcement |
| Version Model Number | FS2030 |
| Catalog Number | FS2030 |
| Company DUNS | 967358115 |
| Company Name | W. L. Gore & Associates, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| 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 | 30 Centimeter |
| Length | 30 Centimeter |
| Length | 30 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Width | 20 Centimeter |
| Length | 30 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00733132605453 [Primary] |
| HIBCC | H373FS20303 [Secondary] |
| OWZ | Mesh, surgical, absorbable, thoracic, chest wall reconstruction |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-10-28 |
| Device Publish Date | 2017-02-13 |
| 00733132606139 | FLAT SHEET 7 X 10 CM - 1PK |
| H373FS20303 | FLAT SHEET 20 X 30 CM - 1PK |
| 00733132605446 | FLAT SHEET 20 X 20 CM - 1PK |
| 00733132605439 | FLAT SHEET 10 X 30 CM - 1PK |
| H373FS091533 | FLAT SHEET 9 X 15 CM - 1PK |
| H373FS080834 | FLAT SHEET 8 X 8 CM - 1PK |