RONGEUR

Basic Information

• Brand Name: RONGEUR
• Primary DI: B974KR60CS0
• Version / Model: KLEINERT-KUTZ RONGEUR
• Catalog Number: KR60CS
• Company Name: DR.FRIGZ INTERNATIONAL(PVT)LTD,
• Labeler DUNS: 645680125
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-21
• Public Version: 2
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: 9de69795-7f2d-4382-bf18-ef8ee5b98cac

Device Description

KLEINERT-KUTZ DOUBLE ACTION RONGEUR FULL CURVE 3MM X 8MM BITE 6 INCH

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EMH	Forceps, Rongeur, Surgical	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62490	Dressing/utility forceps, scissors-like, single-use	A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is not intended for endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B974KR60CS0	HIBCC

Device Sizes

Type	Value	Unit	Text
Length	6	Inch