Novilase 100001-01

GUDID 00860008944825

General/multiple surgical diode laser system

Primary Device ID	00860008944825
NIH Device Record Key	d788aa1e-0484-407e-807e-e8a35d8a9e9b
Commercial Distribution Status	In Commercial Distribution
Brand Name	Novilase
Version Model Number	LTS 2.1 (USA)
Catalog Number	100001-01
Company DUNS	011736427
Company Name	Novian Health 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	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
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	00860008944825 [Primary]

GEX	Powered Laser Surgical Instrument

Steralize Prior To Use	false
Device Is Sterile	false

00860008944825	Novilase Laser Therapy System for focal destruction breast tumors.
00860008944887	Novilase Laser Therapy System for focal destruction breast tumors. For distribution in the UK.
00860008944870	Novilase Laser Therapy System for focal destruction breast tumors. For distribution in Europe an

Mark Image Registration \| Serial	Company Trademark Application Date
NOVILASE 77407877 3755293 Live/Registered	NOVIAN HEALTH INC. 2008-02-27