Kirwan

Basic Information

• Brand Name: Kirwan
• Primary DI: 00841019122648
• Version / Model: 19-2236PLIR
• Company Name: KIRWAN SURGICAL PRODUCTS LLC
• Labeler DUNS: 046355210
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-22
• Public Version: 1
• Public Version Date: 2025-01-30
• Public Version Status: New
• Public Device Record Key: ed12056c-6242-46da-afdf-fcbd26da4e04

Device Description

DISPOSABLE BIPOLAR FORCEPS, 8" (20.3 cm), POLARIS NON STICK IRRIGATING, 1.5mm TIP, INSULATED

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
56296	Open-surgery electrosurgical handpiece/electrode, bipolar, single-use	A sterile rigid combined electrosurgical handpiece and bipolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10841019122645	GS1		5	In Commercial Distribution
Primary	00841019122648	GS1
Package	20841019122642	GS1		25	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K900533	000