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 |
Phone | 877-408-9628 |
customerservice@neotract.com | |
Phone | 877-408-9628 |
customerservice@neotract.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00814932020001 [Primary] |
GS1 | 10814932020008 [Package] Package: Shelf Carton [4 Units] In Commercial Distribution |
PEW | Implantable Transprostatic Tissue Retractor System |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-09-26 |
Device Publish Date | 2015-09-14 |
10814932020046 | UL400-4 |
00814932020001 | UL400-4 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() UROLIFT 87296231 5256109 Live/Registered |
Neotract, Inc. 2017-01-10 |
![]() UROLIFT 77184568 3609328 Live/Registered |
Neotract, Inc. 2007-05-18 |