| Primary Device ID | B384VS074325 |
| NIH Device Record Key | f1f6a18e-1398-4b7c-a8b7-59f72e464c9e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACTU8 End-Grip Forceps |
| Version Model Number | 25ga End-Grip Forceps |
| Catalog Number | VS0743.25 |
| Company DUNS | 080375891 |
| Company Name | VORTEX SURGICAL, LLC |
| 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 | false |
| 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 | 6367784350 |
| info@vortexsurgical.com | |
| Phone | 6367784350 |
| info@vortexsurgical.com | |
| Phone | 6367784350 |
| info@vortexsurgical.com | |
| Phone | 6367784350 |
| info@vortexsurgical.com | |
| Phone | 6367784350 |
| info@vortexsurgical.com | |
| Phone | 6367784350 |
| info@vortexsurgical.com | |
| Phone | 6367784350 |
| info@vortexsurgical.com | |
| Phone | 6367784350 |
| info@vortexsurgical.com | |
| Phone | 6367784350 |
| info@vortexsurgical.com | |
| Phone | 6367784350 |
| info@vortexsurgical.com | |
| Phone | 6367784350 |
| info@vortexsurgical.com | |
| Phone | 6367784350 |
| info@vortexsurgical.com | |
| Phone | 6367784350 |
| info@vortexsurgical.com | |
| Phone | 6367784350 |
| info@vortexsurgical.com | |
| Phone | 6367784350 |
| info@vortexsurgical.com | |
| Phone | 6367784350 |
| info@vortexsurgical.com | |
| Phone | 6367784350 |
| info@vortexsurgical.com |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B384VS074325 [Primary] |
| HNR | Forceps, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-12 |
| Device Publish Date | 2018-10-11 |
| B384VS074325 | ACTU8 End-Grip Forceps |
| B384VS074323 | ACTU8 End-Grip Forceps |