LigaSure

Basic Information

• Brand Name: LigaSure
• Primary DI: 10884521199392
• Version / Model: LF3225C
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-22
• Public Version: 11
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: afbf6881-c1a9-41c5-a162-0adc41888e4e

Device Description

Curved Jaw, Open Reusable Clamp

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44680	Electrosurgical handpiece, reusable	A hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to the generator; it is not intended for use during inert gas-enhanced electrosurgery. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521199399	GS1	PACK_OR_INNER_PACK	3	In Commercial Distribution
Primary	10884521199392	GS1
Direct Marking	10884521780446	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K160331	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			2.5 cm - 25 cm;
Length	25	Centimeter
Width	2.5	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -29 – 149 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 25 – 85 Percent (%) Relative Humidity