I² Kit for intraocular injection VS0500

GUDID B384VS05001

Ophthalmic surgical procedure kit, non-medicated, single-use

Primary Device ID	B384VS05001
NIH Device Record Key	cc0f0ed9-1a1f-466d-98d9-f75350f55d26
Commercial Distribution Status	In Commercial Distribution
Brand Name	I² Kit for intraocular injection
Version Model Number	VS0500
Catalog Number	VS0500
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	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	B384VS05001 [Primary]

KDD	Kit, Surgical Instrument, Disposable

Steralize Prior To Use	false
Device Is Sterile	true

B384VS05201	Intraocular injection kit - standard set with drape (speculum, marker, drape, 18ga needle, 27ga
B384VS05101	Intraocular injection kit - standard set (speculum, marker, 18ga needle, 27ga needle, 30ga needl
B384VS05001	Intraocular Injection Kit - contains blade speculum and scleral marker