UROLIFT UL2-CHK

GUDID 10814932020206

TELEFLEX INCORPORATED

Prostatic retraction implant Prostatic retraction implant Prostatic retraction implant Prostatic retraction implant Prostatic retraction implant Prostatic retraction implant Prostatic retraction implant Prostatic retraction implant Prostatic retraction implant Prostatic retraction implant Prostatic retraction implant Prostatic retraction implant Prostatic retraction implant Prostatic retraction implant Prostatic retraction implant Prostatic retraction implant Prostatic retraction implant Prostatic retraction implant Prostatic retraction implant Prostatic retraction implant Prostatic retraction implant Prostatic retraction implant Prostatic retraction implant Prostatic retraction implant Prostatic retraction implant Prostatic retraction implant Prostatic retraction implant Prostatic retraction implant

• Primary Device ID: 10814932020206
• NIH Device Record Key: bff4f689-9afd-4747-bbb7-8e33dd646d09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UROLIFT
• Version Model Number: IPN056885
• Catalog Number: UL2-CHK
• 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: true
• 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
• 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
• 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	10814932020206 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201837

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: 2021-06-29
• Device Publish Date: 2021-06-21

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