UroLift® 2 UL500-C

GUDID 10814932020022

NEOTRACT, INC.

Prostatic retraction implant

• Primary Device ID: 10814932020022
• NIH Device Record Key: ab622147-25b3-4417-863f-e771e56cd305
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UroLift® 2
• Version Model Number: UL500-C
• Catalog Number: UL500-C
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814932020025 [Primary]
GS1	10814932020022 [Package]; Contains: 00814932020025; Package: Shelf Carton [8 Units]; Discontinued: 2017-11-01; Not in Commercial Distribution
GS1	20814932020029 [Package]; Contains: 00814932020025; Package: Shelf Carton [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162345

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-25
• Device Publish Date: 2016-11-15

On-Brand Devices [UroLift® 2]

• 10814932020039: UL500-H
• 10814932020022: UL500-C
• 10814932020015: UL500-H