FasTac® Flex

Basic Information

• Brand Name: FasTac® Flex
• Primary DI: 00821329001635
• Version / Model: 201600-005
• Catalog Number: 6201 FAS
• Company Name: Greatbatch Ltd
• Labeler DUNS: 968623467
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-12
• Public Version: 2
• Public Version Date: 2021-06-10
• Public Version Status: Update
• Public Device Record Key: 638fc9a9-b978-4994-8b9d-943eb7ca8674

Device Description

Steerable Lead Implant Tool

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	870.4500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62715	Epicardial pacing lead inserter	A sterile, manually-powered, mechanical surgical instrument designed for the implantation of a pacing lead in the epicardium. It is a hand-held, shaft-like tool with a mechanical trigger and rotatable thumbwheel designed to deploy the distally-mounted lead and then fix it in the epicardium by rotation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00821329001635	GS1