SurgiTouch™ Scanner

Basic Information

• Brand Name: SurgiTouch™ Scanner
• Primary DI: 07290109142203
• Version / Model: kit for AcuPulse and AcuPulse DUO
• Catalog Number: KT-1000100
• Company Name: LUMENIS LTD.
• Labeler DUNS: 600166524
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-30
• Public Version: 6
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: 3a6faa70-c8ec-4a24-82a6-5c11a1f47c8a
• Distribution End Date: 2023-12-04

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

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	07290109142203	GS1

Customer Contacts

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