UroLift UL400-4

GUDID 10814932020046

NEOTRACT, INC.

Prostatic retraction implant

• Primary Device ID: 10814932020046
• NIH Device Record Key: b68ac78b-5709-4084-a9c2-670118a02e30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UroLift
• Version Model Number: UL400-4
• Catalog Number: UL400-4
• Company DUNS: 623519464
• Company Name: NEOTRACT, INC.
• 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: 877-408-9628
• Email: customerservice@neotract.com
• Phone: 877-408-9628
• Email: customerservice@neotract.com
• Phone: 877-408-9628
• Email: customerservice@neotract.com
• Phone: 877-408-9628
• Email: customerservice@neotract.com
• Phone: 877-408-9628
• Email: customerservice@neotract.com
• Phone: 877-408-9628
• Email: customerservice@neotract.com
• Phone: 877-408-9628
• Email: customerservice@neotract.com
• Phone: 877-408-9628
• Email: customerservice@neotract.com
• Phone: 877-408-9628
• Email: customerservice@neotract.com
• Phone: 877-408-9628
• Email: customerservice@neotract.com
• Phone: 877-408-9628
• Email: customerservice@neotract.com
• Phone: 877-408-9628
• Email: customerservice@neotract.com
• Phone: 877-408-9628
• Email: customerservice@neotract.com
• Phone: 877-408-9628
• Email: customerservice@neotract.com
• Phone: 877-408-9628
• Email: customerservice@neotract.com
• Phone: 877-408-9628
• Email: customerservice@neotract.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814932020049 [Primary]
GS1	10814932020046 [Package]; Contains: 00814932020049; Package: Shelf Carton [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173087

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: 2018-10-26
• Device Publish Date: 2018-09-25

On-Brand Devices [UroLift]

• 10814932020046: UL400-4
• 00814932020001: UL400-4