BARBED TUNNELER

Basic Information

• Brand Name: BARBED TUNNELER
• Primary DI: 00884908089370
• Version / Model: MR7STUN
• Company Name: Medical Components, Inc.
• Labeler DUNS: 038000253
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-08
• Public Version: 4
• Public Version Date: 2021-02-04
• Public Version Status: Update
• Public Device Record Key: 88881477-4a2f-4bec-a876-374201ff98ae
• Distribution End Date: 2021-01-29

Device Description

0.074" BARBED TUNNELER FOR 7F PRO-LINE®

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
MZY	Graft,vascular,stainless steel tunneler	Cardiovascular	870.3450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35950	Vascular graft tunneller	A long, surgical instrument used to tunnel an artificial passageway along vascular tissue planes to create a connecting channel typically for the introduction of a vascular graft or a vascular prosthesis. It can have a variety of designs, but basically it will be a long, round, stiff rod that tapers to a rounded point at the distal tip and have a handle at the proximal end to allow the surgeon to exert the necessary pressure and manipulation to push it through the body tissue. It will typically be made of high-grade stainless steel and possibly other materials for the handle, which may be detachable. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50884908089375	GS1	box	5	Not in Commercial Distribution	2021-01-29
Primary	00884908089370	GS1

Customer Contacts

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