ViziLite® PLS1005

GUDID D813PLS10050

Oral lesion examination light

Primary Device ID	D813PLS10050
NIH Device Record Key	78150ef3-b79e-4f79-8ecd-1632ea177b3d
Commercial Distribution Status	In Commercial Distribution
Brand Name	ViziLite®
Version Model Number	PLS1005
Catalog Number	PLS1005
Company DUNS	809857704
Company Name	DEN-MAT HOLDINGS, 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	false
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	true

Device Issuing Agency	Device ID
HIBCC	D813PLS10050 [Primary]

NXV	Diagnostic Light, Soft Tissue Detector

Steralize Prior To Use	false
Device Is Sterile	false

D813PLS10080	VIZILITE PRO PATIENT EYEWEAR
D813PLS10050	VZLITE PRO Li-ION CHGR W/PLUG
D813PLS10030	VIZILITE PRO SCREENING SYS
D8136501180	VL RETRACTOR MIRROR BLSTR PK

Mark Image Registration \| Serial	Company Trademark Application Date
VIZILITE 85209240 4261859 Live/Registered	Banom, Inc. 2011-01-03
VIZILITE 78544793 3062943 Dead/Cancelled	ZILA, INC. 2005-01-10
VIZILITE 76322277 2670202 Live/Registered	ZILA, INC. 2001-10-09