Primary Device ID | B384VS011020A5 |
NIH Device Record Key | 4c45d34a-8a6e-4536-8dcd-2d4f92ddec2c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | 20ga Straight Laser Probe - Alcon compatible |
Version Model Number | VS0110.20A |
Catalog Number | VS0110.20A |
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 | true |
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 | |
Phone | 636-778-4350 |
info@vortexsurgical.com | |
Phone | 636-778-4350 |
info@vortexsurgical.com |
Needle Gauge | 20 Gauge |
Needle Gauge | 20 Gauge |
Needle Gauge | 20 Gauge |
Needle Gauge | 20 Gauge |
Needle Gauge | 20 Gauge |
Needle Gauge | 20 Gauge |
Needle Gauge | 20 Gauge |
Needle Gauge | 20 Gauge |
Needle Gauge | 20 Gauge |
Needle Gauge | 20 Gauge |
Needle Gauge | 20 Gauge |
Needle Gauge | 20 Gauge |
Needle Gauge | 20 Gauge |
Needle Gauge | 20 Gauge |
Needle Gauge | 20 Gauge |
Needle Gauge | 20 Gauge |
Needle Gauge | 20 Gauge |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B384VS011020A1 [Primary] |
HIBCC | B384VS011020A5 [Package] Contains: B384VS011020A1 Package: Box [10 Units] In Commercial Distribution |
GEX | Powered Laser Surgical Instrument |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-24 |
VS01102319 - 23ga Straight Laser Probe | 2020-02-06 23ga 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 |