FDA.reportPublic FDA data

NURO™

Primary DI
00643169654631
Brand
NURO™
Company
MEDTRONIC, INC.
Model
3533K
Device description
ACCY 3533K THERAPY SESSION KIT
Published
2016-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NAMSTIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAMStimulator, Peripheral Nerve, Non-Implanted, For Urinary IncontinenceGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132561000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132561000NURO NEUROMODULATION SYSTEMAdvanced Uro-Solutions, Inc.2013-11-05NAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169654631PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169654631006431696546316431696546310643169654631

GMDN Terms#

Term, Definition table
TermDefinition
Tibial nerve percutaneous incontinence-control electrical stimulation systemAn assembly of battery-powered devices designed to treat urinary and/or faecal incontinence with electrical stimuli applied to the sacral nerve via percutaneous tibial nerve stimulation (PTNS). It consists of a pair of electrodes, a needle electrode placed into a leg near the ankle and a surface electrode placed on the same leg, and a pulse generator. It produces an adjustable electrical pulse that travels to the sacral nerve plexus via the tibial nerve. It is operated by healthcare personnel who typically apply a predetermined series of treatment sessions to the patient.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
796986144
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20763000946979DLP®872202024-08-15
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850053656026VivallyAvation Medical, Inc.NAM2024-10-29
00850053656033VivallyAvation Medical, Inc.NAM2024-10-29
00860009634022VivallyAvation Medical, Inc.NAM2024-10-29
00860009634039VivallyAvation Medical, Inc.NAM2024-10-29
00860009634053VivallyAvation Medical, Inc.NAM2024-10-29
00860009634046VivallyAvation Medical, Inc.NAM2023-08-01
00860009634077VivallyAvation Medical, Inc.NAM2023-08-01
00860009634084VivallyAvation Medical, Inc.NAM2023-08-01
00860009634008VivallyAvation Medical, Inc.NAM2023-07-31
00860009634015VivallyAvation Medical, Inc.NAM2023-07-31
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