Novilase 100001-03

GUDID 00860008944887

Novilase Laser Therapy System for focal destruction breast tumors. For distribution in the UK.

Novian Health Inc.

General/multiple surgical diode laser system
Primary Device ID00860008944887
NIH Device Record Keyd82e62c3-fce0-44b4-88ab-d770863e22e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameNovilase
Version Model NumberLTS 2.1 (UK)
Catalog Number100001-03
Company DUNS011736427
Company NameNovian Health Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone3122667200
Emailinfo@novianhealth.com
Phone3122667200
Emailinfo@novianhealth.com
Phone3122667200
Emailinfo@novianhealth.com
Phone3122667200
Emailinfo@novianhealth.com
Phone3122667200
Emailinfo@novianhealth.com
Phone3122667200
Emailinfo@novianhealth.com
Phone3122667200
Emailinfo@novianhealth.com
Phone3122667200
Emailinfo@novianhealth.com
Phone3122667200
Emailinfo@novianhealth.com
Phone3122667200
Emailinfo@novianhealth.com
Phone3122667200
Emailinfo@novianhealth.com
Phone3122667200
Emailinfo@novianhealth.com
Phone3122667200
Emailinfo@novianhealth.com
Phone3122667200
Emailinfo@novianhealth.com
Phone3122667200
Emailinfo@novianhealth.com
Phone3122667200
Emailinfo@novianhealth.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860008944887 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-23
Device Publish Date2023-11-15

On-Brand Devices [Novilase]

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

Trademark Results [Novilase]

Mark Image

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

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