| Primary Device ID | VS01102517 |
| NIH Device Record Key | fb1a8de3-5fc6-4828-8767-e9a52d0998ec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 25ga Straight Laser Probe |
| Version Model Number | VS0110.25 |
| Catalog Number | VS0110.25 |
| Company DUNS | 080375891 |
| Company Name | VORTEX SURGICAL, LLC |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | VS01102517 [Primary] |
| HQB | Photocoagulator And Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2020-01-29 |
| VS01102319 - 23ga Straight Laser Probe | 2020-02-06 23ga Straight Laser Probe |
| VS01102517 - 25ga Straight Laser Probe | 2020-02-0625ga Straight Laser Probe |
| VS01102517 - 25ga Straight Laser Probe | 2020-02-06 25ga Straight Laser Probe |
| VS01102719 - 27ga Straight Laser Probe | 2020-02-06 27ga Straight Laser Probe |
| VS01202316 - 23ga Curved Laser Probe | 2020-02-06 23ga Curved Laser Probe |
| VS01202518 - 25ga Curved Laser Probe | 2020-02-06 25ga Curved Laser Probe |
| VS02251 - NANO SubRet Gateway Device | 2020-01-31 28ga Delivery Device for transcleral procedures |
| B384VS05001 - I² Kit for intraocular injection | 2019-11-08 Intraocular Injection Kit - contains blade speculum and scleral marker |
| B384VS05101 - I² Kit for intraocular injection | 2019-11-08 Intraocular injection kit - standard set (speculum, marker, 18ga needle, 27ga needle, 30ga needle, gloves, swabs, 1.0 ml syringe |