NANO SubRet Gateway Device VS0225

GUDID VS02251

28ga Delivery Device for transcleral procedures

VORTEX SURGICAL, LLC

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Primary Device IDVS02251
NIH Device Record Key8c907c5f-9b6f-4e76-ba3a-d8e7a37b2b2c
Commercial Distribution StatusIn Commercial Distribution
Brand NameNANO SubRet Gateway Device
Version Model NumberVS0225
Catalog NumberVS0225
Company DUNS080375891
Company NameVORTEX SURGICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com
Phone636-778-4350
Emailinfo@vortexsurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCVS02251 [Primary]

FDA Product Code

HMXCannula, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-31
Device Publish Date2020-01-23

Devices Manufactured by VORTEX SURGICAL, LLC

VS01102319 - 23ga Straight Laser Probe2020-02-06 23ga Straight Laser Probe
VS01102517 - 25ga Straight Laser Probe2020-02-06 25ga Straight Laser Probe
VS01102719 - 27ga Straight Laser Probe2020-02-06 27ga Straight Laser Probe
VS01202316 - 23ga Curved Laser Probe2020-02-06 23ga Curved Laser Probe
VS01202518 - 25ga Curved Laser Probe2020-02-06 25ga Curved Laser Probe
VS02251 - NANO SubRet Gateway Device2020-01-3128ga Delivery Device for transcleral procedures
VS02251 - NANO SubRet Gateway Device2020-01-31 28ga Delivery Device for transcleral procedures
B384VS05001 - I² Kit for intraocular injection2019-11-08 Intraocular Injection Kit - contains blade speculum and scleral marker
B384VS05101 - I² Kit for intraocular injection2019-11-08 Intraocular injection kit - standard set (speculum, marker, 18ga needle, 27ga needle, 30ga needle, gloves, swabs, 1.0 ml syringe
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