NURO™

GUDID 00763000157487

ENS 3533A NURO EXTRNL NEUROSTIMULATOR US

MEDTRONIC, INC.

Tibial nerve percutaneous incontinence-control electrical stimulation system
Primary Device ID00763000157487
NIH Device Record Key50e48c49-83b1-4415-8d45-504547742364
Commercial Distribution StatusIn Commercial Distribution
Brand NameNURO™
Version Model Number3533A
Company DUNS796986144
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000157487 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NAMStimulator, peripheral nerve, non-implanted, for pelvic floor dysfunction

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-22
Device Publish Date2018-12-22

On-Brand Devices [NURO™]

00643169654631ACCY 3533K THERAPY SESSION KIT
00643169654624ENS 3533 NURO EXTERNAL NEUROSTIMULATOR
00763000157487ENS 3533A NURO EXTRNL NEUROSTIMULATOR US

Trademark Results [NURO]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NURO
NURO
98463011 not registered Live/Pending
WaveCel, LLC
2024-03-22
NURO
NURO
98463005 not registered Live/Pending
WaveCel, LLC
2024-03-22
NURO
NURO
97265887 not registered Live/Pending
Medtronic, Inc.
2022-02-14
NURO
NURO
90574695 not registered Live/Pending
Fillmore, Daniel T
2021-03-11
NURO
NURO
90477722 not registered Live/Pending
2695174 Ontario Inc.
2021-01-20
NURO
NURO
90151909 not registered Live/Pending
The Marley Company, LLC
2020-09-01
NURO
NURO
88716271 not registered Live/Pending
Innovative Services and Solutions, LLC
2019-12-05
NURO
NURO
88716263 not registered Live/Pending
Innovative Services and Solutions, LLC
2019-12-05
NURO
NURO
87984134 not registered Live/Pending
Nuro, Inc.
2018-01-22
NURO
NURO
87764793 not registered Live/Pending
Nuro, Inc.
2018-01-22
NURO
NURO
87418395 not registered Live/Pending
NURO CORP.
2017-04-20
NURO
NURO
86759504 not registered Live/Pending
Anton & Irene, LLC
2015-09-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.