UroLift UL400-4

GUDID 00814932020001

NEOTRACT, INC.

Prostatic retraction implant

• Primary Device ID: 00814932020001
• NIH Device Record Key: 94e9bda0-9ed2-4f71-9d42-446761d72fbc
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814932020001 [Primary]
GS1	10814932020008 [Package]; Package: Shelf Carton [4 Units]; In Commercial Distribution

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: 3
• Public Version Date: 2018-09-26
• Device Publish Date: 2015-09-14

On-Brand Devices [UroLift]

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