UROLIFT UL400ATC

GUDID 20814932020142

UroLift ATC System

TELEFLEX INCORPORATED

Prostatic retraction implant

• Primary Device ID: 20814932020142
• NIH Device Record Key: 5ef57ee1-be9c-4f72-a9eb-065e960ccff6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UROLIFT
• Version Model Number: IPN056288
• Catalog Number: UL400ATC
• Company DUNS: 002348191
• Company Name: TELEFLEX INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1(925)401-0700
• Email: uroliftcustomer@teleflex.com
• Phone: +1(925)401-0700
• Email: uroliftcustomer@teleflex.com
• Phone: +1(925)401-0700
• Email: uroliftcustomer@teleflex.com
• Phone: +1(925)401-0700
• Email: uroliftcustomer@teleflex.com
• Phone: +1(925)401-0700
• Email: uroliftcustomer@teleflex.com
• Phone: +1(925)401-0700
• Email: uroliftcustomer@teleflex.com
• Phone: +1(925)401-0700
• Email: uroliftcustomer@teleflex.com
• Phone: +1(925)401-0700
• Email: uroliftcustomer@teleflex.com
• Phone: +1(925)401-0700
• Email: uroliftcustomer@teleflex.com
• Phone: +1(925)401-0700
• Email: uroliftcustomer@teleflex.com
• Phone: +1(925)401-0700
• Email: uroliftcustomer@teleflex.com
• Phone: +1(925)401-0700
• Email: uroliftcustomer@teleflex.com
• Phone: +1(925)401-0700
• Email: uroliftcustomer@teleflex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10814932020145 [Primary]
GS1	20814932020142 [Package]; Contains: 10814932020145; Package: Carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200441

FDA Product Code

• PEW: Implantable transprostatic tissue retractor system

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: 2020-07-20
• Device Publish Date: 2020-07-10

On-Brand Devices [UROLIFT]

• 10814932020084: UroLift System
• 20814932020142: UroLift ATC System
• 20814932020159: UroLift System
• 20814932020135: UroLift 2 Delivery Handle, U.S.
• 20814932020128: UroLift 2 Implant Cartridge
• 00814932020056: UROLIFT PROCEDURE KIT STERILIZATION TRAY
• 20814932020210: UroLift System
• 10814932020206: IPN056885
• 20814932020296: UroLift 2 Implant Cartridge
• 20814932020289: UroLift 2 Implant Cartridge Handle Kit
• 20814932020197: UroLift System Rigid Retrieval Kit Sterilization Tray
• 20814932020272: UroLift System
• 20814932020265: UroLift System
• 20814932020357: UroLift 2 Implant Cartridge Handle Kit
• 20814932020340: UroLift 2 Implant Cartridge
• 20814932020395: UroLift System
• 20814932020388: UroLift System
• 20814932020401: UroLift ATC System
• 20814932020364: UroLift UL2 ATC Implant Cartridge
• 20814932020456: UroLift UL2 ATC Implant Cartridge
• 10814932021470: UroLift 2 Implant Cartridge Handle Kit
• 20814932020449: IPN928811
• 10814932020527: UroLift 2 Implant Cartridge Handle Kit
• 20814932020500: UroLift 2 Implant Cartridge