| Primary Device ID | 00850047730060 |
| NIH Device Record Key | c6266fe5-c262-4e5f-9219-d756e612aa88 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Foundation DRS Solo |
| Version Model Number | FS1-F-1025 |
| Company DUNS | 080325588 |
| Company Name | Bionova Medical Inc. |
| 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 | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Length | 10 Centimeter |
| Width | 25 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850047730060 [Primary] |
| FTM | Mesh, Surgical |
| 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 | 2023-07-13 |
| Device Publish Date | 2023-07-05 |
| 00850047730077 | Fenestrated |
| 00850047730060 | Fenestrated |
| 00850047730053 | Fenestrated |
| 00850047730046 | Fenestrated |
| 00850047730039 | FS1-2025 |
| 00850047730022 | FS1-1025 |
| 00850047730015 | FS1-1012 |
| 00850047730008 | FS1-0505 |