UroLift® 2

Basic Information

• Brand Name: UroLift® 2
• Primary DI: 00814932020018
• Version / Model: UL500-H
• Catalog Number: UL500-H
• Company Name: NEOTRACT, INC.
• Labeler DUNS: 623519464
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-15
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 55aa5b6d-3bc1-4347-93f5-0f0d1a45402d
• Distribution End Date: 2017-11-01

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PEW	Implantable Transprostatic Tissue Retractor System	Gastroenterology, Urology	876.5530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58882	Prostatic retraction implant	A sterile implantable device intended to increase prostatic urethral patency, and thereby relieve lower urinary tract symptoms (LUTS) due to benign prostatic hypertrophy (BPH), by physically compressing the prostate gland by retraction. The implant is in the form of a two orthogonal tags (e.g., metal) held together by a suture (e.g., monofilament), and is introduced so that one tag is outside the prostatic capsule and the other is in the urethra, with the suture providing retraction. It is not intended to be explanted. The device is implanted using a dedicated, single-use, hand-held, pistol-like delivery device through the sheath of a rigid endoscope.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10814932020015	GS1	Shelf Carton	2	Not in Commercial Distribution	2017-11-01
Primary	00814932020018	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]