| Primary Device ID | B384VS0290 |
| NIH Device Record Key | 95a64f36-7b86-4a52-9eb0-3d85feb4fb67 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EDD - External Drainage and Depression Device |
| Version Model Number | Straight |
| Catalog Number | VS0290 |
| Company DUNS | 080375891 |
| Company Name | Vortex Surgical, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 636-778-4350 |
| info@vortexsurgical.com | |
| Phone | 636-778-4350 |
| info@vortexsurgical.com | |
| Phone | 636-778-4350 |
| info@vortexsurgical.com | |
| Phone | 636-778-4350 |
| info@vortexsurgical.com | |
| Phone | 636-778-4350 |
| info@vortexsurgical.com | |
| Phone | 636-778-4350 |
| info@vortexsurgical.com | |
| Phone | 636-778-4350 |
| info@vortexsurgical.com | |
| Phone | 636-778-4350 |
| info@vortexsurgical.com | |
| Phone | 636-778-4350 |
| info@vortexsurgical.com | |
| Phone | 636-778-4350 |
| info@vortexsurgical.com | |
| Phone | 636-778-4350 |
| info@vortexsurgical.com | |
| Phone | 636-778-4350 |
| info@vortexsurgical.com | |
| Phone | 636-778-4350 |
| info@vortexsurgical.com | |
| Phone | 636-778-4350 |
| info@vortexsurgical.com | |
| Phone | 636-778-4350 |
| info@vortexsurgical.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B384VS0290 [Primary] |
| HMX | Cannula, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-11-21 |
| Device Publish Date | 2019-08-26 |
| 00810123481828 - Vortex Surgical Inc. | 2025-04-28 23ga ACTU8 Talon ILM Forceps |
| 00810123481835 - Vortex Surgical Inc. | 2025-04-28 25ga ACTU8 Talon ILM Forceps |
| 00810123482313 - Vortex Surgical Inc. | 2025-04-28 23ga ACTU8 Talon End-Grip Forceps |
| 00810123482337 - Vortex Surgical Inc. | 2025-04-28 25ga ACTU8 Talon End-Grip Forceps |
| 00810123482382 - Vortex Surgical Inc. | 2025-04-28 23ga ACTU8 Talon Pro-Grip Forceps |
| 00810123482375 - Vortex Surgical Inc. | 2025-04-28 25ga ACTU8 Talon Pro-Grip Forceps |
| 00810123482788 - Vortex Surgical Inc. | 2025-04-28 27ga ACTU8 Talon Pro-Grip Forceps |
| 00810123482801 - Vortex Surgical Inc. | 2025-04-28 27ga ACTU8 Talon End-Grip Forceps |