LigaSure

Basic Information

• Brand Name: LigaSure
• Primary DI: 10884521521735
• Version / Model: LF5637
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-03
• Public Version: 7
• Public Version Date: 2023-10-26
• Public Version Status: Update
• Public Device Record Key: d78e96c8-7296-4c2d-9b78-b0c7b310a197

Device Description

Retractable L-Hook Laparoscopic Sealer/Divider

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
57944	Endoscopic electrosurgical handpiece/electrode, bipolar, single-use	A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery; it is not intended for focal percutaneous ablation. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521521732	GS1	CASE	6	In Commercial Distribution
Primary	10884521521735	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K161804	000

Device Sizes

Type	Value	Unit	Text
Length	37	Centimeter
Outer Diameter	5	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry
• Type: Handling Environment Temperature
• Temperature Range: -22 – 140 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 25 – 85 Percent (%) Relative Humidity