FiberLase™ HP-M 140 mm malleable

Basic Information

• Brand Name: FiberLase™ HP-M 140 mm malleable
• Primary DI: 07290109141114
• Version / Model: FiberLase™ HP-M 140 mm malleable
• Catalog Number: AC-1083940
• Company Name: LUMENIS LTD.
• Labeler DUNS: 600166524
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-25
• Public Version: 6
• Public Version Date: 2023-10-09
• Public Version Status: Update
• Public Device Record Key: 50ab0d0b-6ec3-4142-adf6-746822e6a905

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: Yes
• 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
17774	General/multiple surgical solid-state/carbon dioxide laser system	A mains electricity (AC-powered) device assembly designed to produce two distinct high-power laser beams, one solid-state [e.g., neodymium-doped yttrium-aluminium-garnet (Nd:YAG)] mediated and the other carbon dixoide (CO2) mediated, intended for bloodless incisions during general surgery and/or multiple specialized surgical applications (non-dedicated). It is intended to provide both the cutting capabilities of gas mediated lasing, and the haemostatic abilities of solid-state mediated lasing. It includes a light source, delivery/positioning device(s), and controls/foot-switch. It does not include frequency doubling technology.	No	Active
61474	General/multiple surgical laser system beam guide, reusable	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 reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290109141114	GS1
Direct Marking	07290109143781	GS1

Customer Contacts

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