TLC-II® SYSTEM DRIVER

Basic Information

• Brand Name: TLC-II® SYSTEM DRIVER
• Primary DI: 00813024013396
• Version / Model: 100621
• Catalog Number: 100621
• Company Name: Thoratec Corporation
• Labeler DUNS: 070156955
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-20
• Public Version: 8
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: d0d5067a-0b64-48ac-923d-8a63636713a6

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DSQ	Ventricular (Assisst) Bypass	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
37315	Implantable ventricular circulatory assist system control unit	An electrically-powered external component of an implantable ventricular circulatory assist system intended to supply power to the implanted system pump via a percutaneous lead (not included). It is typically a belt worn device used as a bridge to transplantation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813024013396	GS1

Customer Contacts

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