Kirwan

Basic Information

• Brand Name: Kirwan
• Primary DI: 00841019118498
• Version / Model: 19-1221C
• Company Name: KIRWAN SURGICAL PRODUCTS LLC
• Labeler DUNS: 046355210
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-12
• Public Version: 1
• Public Version Date: 2020-09-21
• Public Version Status: New
• Public Device Record Key: 47addcf1-53e4-41e0-aef3-2bcb5ad05df0

Device Description

Disposable 8 1/2" Hardy Bayonet Stainless Steel Bipolar Forceps, Insulated, Angled 1.0mm Tip with 12' Cord

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	10841019118495	GS1	Chipboard Box	10	In Commercial Distribution
Primary	00841019118498	GS1
Package	20841019118492	GS1	Carton	50	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K900533	000

Device Sizes

Type	Value	Unit	Text
Length	8.5	Inch