I² Kit for intraocular injection VS0520

GUDID B384VS05201

Intraocular injection kit - standard set with drape (speculum, marker, drape, 18ga needle, 27ga needle, 30ga needle, gloves, swabs, 1.0 ml syringe)

VORTEX SURGICAL, LLC

Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use
Primary Device IDB384VS05201
NIH Device Record Key90f27c0b-8a7e-4a5d-8af8-d9adb8d1b31f
Commercial Distribution StatusIn Commercial Distribution
Brand NameI² Kit for intraocular injection
Version Model NumberVS0520
Catalog NumberVS0520
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
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
Phone636-778-4350
Emailinfo@vortexsurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB384VS05201 [Primary]

FDA Product Code

KDDKit, Surgical Instrument, Disposable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-08
Device Publish Date2016-12-07

On-Brand Devices [I² Kit for intraocular injection]

B384VS05201Intraocular injection kit - standard set with drape (speculum, marker, drape, 18ga needle, 27ga
B384VS05101Intraocular injection kit - standard set (speculum, marker, 18ga needle, 27ga needle, 30ga needl
B384VS05001Intraocular Injection Kit - contains blade speculum and scleral marker
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