KMEDIC

Basic Information

• Brand Name: KMEDIC
• Primary DI: 24026704272550
• Version / Model: IPN013991
• Catalog Number: KM46732
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-15
• Public Version: 2
• Public Version Date: 2019-12-16
• Public Version Status: Update
• Public Device Record Key: fa0de812-ea53-4acf-8684-78a2c659168d

Device Description

BUNNELL TENDON STRIPPER 6" 5 MILLIMETER

Device Characteristics

• Single Use: No
• 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: 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: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HRT	STRIPPER, SURGICAL	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35380	Tendon stripper	A hand-held manual surgical instrument designed to excise a length of ligament, tendon or fascia for use as a living graft. It typically consists of a handle and a semicircular shaped trough that terminates in a sharp cutting edge. It is typically made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	24026704272550	GS1
Direct Marking	04026704272556	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			5MM
Length	15.2	Centimeter