Novilase Laser Therapy Pack 100011-02

GUDID 00860008944801

Procedure pack for Novilase Laser Therapy System containing single-use disposables for laser ablation procedure. Pack contains sterile kit with (1) 110 mm laser probe with removable stylet and 1 temperature sensor, (1) 110 mm thermal probe with 5 temperature sensors, (1) optical fiber, and (1) probe guide; and (1) 30 ml sterile syringe. For distribution in USA/EU/UK.

Novian Health Inc.

General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use
Primary Device ID00860008944801
NIH Device Record Keyab153fb4-af2b-4afd-b454-f144c386176d
Commercial Distribution StatusIn Commercial Distribution
Brand NameNovilase Laser Therapy Pack
Version Model NumberUSA/EU/UK: 110 mm
Catalog Number100011-02
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 Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
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
Phone3122667200
Emailinfo@novianhealth.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860008944801 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-20
Device Publish Date2023-11-12

On-Brand Devices [Novilase Laser Therapy Pack]

00860008944801Procedure pack for Novilase Laser Therapy System containing single-use disposables for laser abl
00860008944894Procedure pack for Novilase Laser Therapy System containing single-use disposables for laser abl
00860008944818Procedure pack for Novilase Laser Therapy System containing single-use disposables for laser abl
00196852073344Procedure pack for Novilase Laser Therapy System containing single-use disposables for laser abl
00860011448006Procedure pack for Novilase Laser Therapy System containing single-use disposables for laser abl
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.