UltraPulse® Focused Incisional Handpiece Set

Basic Information

• Brand Name: UltraPulse® Focused Incisional Handpiece Set
• Primary DI: 07290109141619
• Version / Model: UltraPulse® Focused Incisional Handpiece Set
• Catalog Number: 0614-963-01
• Company Name: LUMENIS LTD.
• Labeler DUNS: 600166524
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-28
• Public Version: 7
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: 82fe39a7-8e85-4a13-859c-03eb4a0c8353
• Distribution End Date: 2023-12-04

Device Description

Additional DM UDI: 07290109144528

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63306	Surgical laser system beam-focus handpiece	A noninvasive hand-held device intended to be connected to the beam guide of a surgical laser system to focus the laser beam during delivery to the target tissue. It is in the form of a rigid cylinder with integrated lenses which focus laser beam wavelengths for surgical applications. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290109141619	GS1
Direct Marking	07290109144511	GS1

Customer Contacts

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