Primary Device ID | VS02251 |
NIH Device Record Key | 8c907c5f-9b6f-4e76-ba3a-d8e7a37b2b2c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | NANO SubRet Gateway Device |
Version Model Number | VS0225 |
Catalog Number | VS0225 |
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 | 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 | |
Phone | 636-778-4350 |
info@vortexsurgical.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | VS02251 [Primary] |
HMX | Cannula, 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 | 2020-01-31 |
Device Publish Date | 2020-01-23 |
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 | 2020-01-3128ga Delivery Device for transcleral procedures |
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 |