Redfield IRC 2100

Basic Information

• Brand Name: Redfield IRC 2100
• Primary DI: 00888937013252
• Version / Model: RIRC-DT6210
• Company Name: Coopersurgical, Inc.
• Labeler DUNS: 801895244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 5
• Public Version Date: 2024-02-28
• Public Version Status: Update
• Public Device Record Key: 2615a0c1-2309-46fa-b2a5-3abca8f0743f

Device Description

Contact Tip/Sheath

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: 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: 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
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	876.4300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47757	Infrared tissue coagulation system handpiece	A hand-operated surgical device that is a component of an infrared tissue coagulation system and designed to activate and direct the infrared (IR) light applied to blood vessels and soft tissues for haemostasis and/or tissue removal. It typically houses an IR light bulb and is electrically connected to the system's control unit for power. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20888937013256	GS1		10	In Commercial Distribution
Primary	00888937013252	GS1

Premarket Submissions

Submission Number	Supplement Number
K974168	000

Device Sizes

Type	Value	Unit	Text
Length	210	Millimeter
Outer Diameter	6	Millimeter