VELscope 5710

GUDID 07540201000025

Optical medical device procedural cover

Primary Device ID	07540201000025
NIH Device Record Key	18139c60-66ae-4fc8-a03d-c4f5365ac249
Commercial Distribution Status	In Commercial Distribution
Brand Name	VELscope
Version Model Number	VELcap Vx
Catalog Number	5710
Company DUNS	243167546
Company Name	LED Dental Inc
Device Count	1
DM Exempt	false
Pre-market Exempt	false
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	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	07540201000025 [Primary]
GS1	17540201000022 [Package] Package: Dispenser Box-16 [16 Units] In Commercial Distribution
GS1	27540201000029 [Package] Contains: 17540201000022 Package: Corrugate Box-128 [8 Units] In Commercial Distribution
GS1	37540201000026 [Package] Contains: 27540201000029 Package: Master Carton-2048 [16 Units] In Commercial Distribution

NXV	Diagnostic Light, Soft Tissue Detector

Steralize Prior To Use	false
Device Is Sterile	false

00754020100096	VELscope Vx Value Bundle-Basic
00754020100041	VELscope Vx Value Bundle-US
00754020100010	VELscope Vx
07540201000094	VELscope Vx Value Bundle-Basic
07540201000049	VELscope Vx Value Bundle-US
27540201000036	VELsheath Vx
07540201000025	VELcap Vx
07540201000018	VELscope Vx

Mark Image Registration \| Serial	Company Trademark Application Date
VELSCOPE 78510940 3169666 Live/Registered	LED Medical Diagnostics, Inc. 2004-11-03