FDA.reportPublic FDA data

NEOTRACT, INC.

Matched from indexed company URL: Neotract, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30151810823005791775NEOTRACT, INC.1Y2026-01-014155 HOPYARD ROAD Pleasanton CA US 94588
30123599643012359964NEOTRACT, INC.1Y2020-04-251971 Rutan Dr Livermore CA US 94551

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00814932020001UroLift - UL400-4877-408-9628customerservice@neotract.com
00814932020018UroLift® 2 - UL500-H877-408-9628customerservice@neotract.com
00814932020025UroLift® 2 - UL500-C877-408-9628customerservice@neotract.com
00814932020032UroLift® 2 - UL500-H877-408-9628customerservice@neotract.com
00814932020049UroLift - UL400-4877-408-9628customerservice@neotract.com
10814932020015UroLift® 2 - UL500-H877-408-9628customerservice@neotract.com
10814932020022UroLift® 2 - UL500-C877-408-9628customerservice@neotract.com
10814932020046UroLift - UL400-4877-408-9628customerservice@neotract.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2273741491134347K232558UroLift 2 ATC Advanced Tissue Control SystemPEW2023-09-22
2273742042077325K212396UroLift System Rigid Retrieval Kit Sterilization TrayKCT2021-10-22
2273741301540244K201837UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant CartridgePEW2020-07-31
2273742022330325K200441UroLift Advanced Tissue Control (ATC) SystemPEW2020-06-05
1925171188425080K193269UroLift System (UL400)PEW2019-12-20
2273741188425080K193269UroLift System (UL400)PEW2019-12-20
2273741879225730K192781UroLift System Procedure Kit Sterilization TrayKCT2020-04-14
2273741039230025K190377UroLift System UL400PEW2019-03-21
2273741169229336K173087UroLift System (UL400 and UL500)PEW2017-12-28

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PEW72023-09-22
KCT22021-10-22

PMN#

GUDID#