I² Kit for intraocular injection VS0500

GUDID B384VS05001

Intraocular Injection Kit - contains blade speculum and scleral marker

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 IDB384VS05001
NIH Device Record Keycc0f0ed9-1a1f-466d-98d9-f75350f55d26
Commercial Distribution StatusIn Commercial Distribution
Brand NameI² Kit for intraocular injection
Version Model NumberVS0500
Catalog NumberVS0500
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

Phone6367784350
Emailinfo@vortexsurgical.com
Phone6367784350
Emailinfo@vortexsurgical.com
Phone6367784350
Emailinfo@vortexsurgical.com
Phone6367784350
Emailinfo@vortexsurgical.com
Phone6367784350
Emailinfo@vortexsurgical.com
Phone6367784350
Emailinfo@vortexsurgical.com
Phone6367784350
Emailinfo@vortexsurgical.com
Phone6367784350
Emailinfo@vortexsurgical.com
Phone6367784350
Emailinfo@vortexsurgical.com
Phone6367784350
Emailinfo@vortexsurgical.com
Phone6367784350
Emailinfo@vortexsurgical.com
Phone6367784350
Emailinfo@vortexsurgical.com
Phone6367784350
Emailinfo@vortexsurgical.com
Phone6367784350
Emailinfo@vortexsurgical.com
Phone6367784350
Emailinfo@vortexsurgical.com
Phone6367784350
Emailinfo@vortexsurgical.com
Phone6367784350
Emailinfo@vortexsurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB384VS05001 [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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