Novilase Laser Therapy Pack

Basic Information

• Brand Name: Novilase Laser Therapy Pack
• Primary DI: 00860008944801
• Version / Model: USA/EU/UK: 110 mm
• Catalog Number: 100011-02
• Company Name: Novian Health Inc.
• Labeler DUNS: 011736427
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-12
• Public Version: 1
• Public Version Date: 2023-11-20
• Public Version Status: New
• Public Device Record Key: ab153fb4-af2b-4afd-b454-f144c386176d

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
62600	General/multiple surgical laser system beam guide, single-use	A surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials; a fibreoptic cable may be included with the device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860008944801	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]