Kirwan

Basic Information

• Brand Name: Kirwan
• Primary DI: 00841019107744
• Version / Model: 41-6110
• Company Name: KIRWAN SURGICAL PRODUCTS LLC
• Labeler DUNS: 046355210
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-08
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 85ca60e3-5557-426b-8db9-1286c247914e

Device Description

Disposable Cautery Low Temperature, Loop Tip

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: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HQP	Unit, Cautery, Thermal, Battery-Powered	Ophthalmic	886.4115	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45629	Electrocautery system, battery-powered	An assembly of battery-powered devices designed to regulate an electrical current used to heat the electrode tip or wire loop of a cutting instrument intended to burn or sear body tissues during surgery. It is typically used to stop bleeding (cauterization of blood vessels), to treat superficial skin lesions (e.g., removal of warts, removal of gastrointestinal polyps via an appropriate endoscope), or to occlude fallopian tubes during sterilization procedures. It typically consists of a generator, a handpiece, and electrodes. Unlike electrosurgical diathermy, electrocautery does not involve electrical current passing through the patient.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20841019107748	GS1		50	In Commercial Distribution
Primary	00841019107744	GS1
Package	10841019107741	GS1		10	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K062659	000