Zoll Tunnel Graft Kit

Basic Information

• Brand Name: Zoll Tunnel Graft Kit
• Primary DI: 00083208007781
• Version / Model: Tunnel Graft Kit
• Catalog Number: Tunnel Graft Kit
• Company Name: Suncoast Dental, Inc
• Labeler DUNS: 078352849
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-19
• Public Version: 1
• Public Version Date: 2022-04-27
• Public Version Status: New
• Public Device Record Key: 94911e16-c46d-4e94-9e9b-6ebd78a05711

Device Description

Zoll Tunnel Graft Kit used to lift/separate (elevate) or tunnel under the periosteum during surgery. Set of 12 Instruments. Nine Molt/Periosteal instrument ( 3 Straight, 3 Left hand and 3 Right hand) and Three retractors to reflect tissue once released.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• 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
DZN	Instruments, Dental Hand	Dental	872.4565	1

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
Primary	00083208007781	GS1

Customer Contacts

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