FasTac® Flex 6201 FAS

GUDID 00821329001642

Steerable Lead Implant Tool

Greatbatch Ltd

Surgical screwdriver, reusable

• Primary Device ID: 00821329001642
• NIH Device Record Key: fc2390b8-90eb-455c-b89b-026e153ad16d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FasTac® Flex
• Version Model Number: 201600-006
• Catalog Number: 6201 FAS
• Company DUNS: 968623467
• Company Name: Greatbatch Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821329001642 [Primary]

FDA Product Code

• DWS: Instruments, Surgical, Cardiovascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-08-20
• Device Publish Date: 2019-08-12

On-Brand Devices [FasTac® Flex]

• 00821329001666: Steerable Lead Implant Tool
• 00821329001642: Steerable Lead Implant Tool
• 00821329001635: Steerable Lead Implant Tool