FDA.reportPublic FDA data

Urgent® PC Neuromodulation System

Primary DI
08717591240167
Brand
Urgent® PC Neuromodulation System
Company
Uroplasty, Inc.
Model
UPC 250
Catalog number
UPC 250
Device description
Lead Set
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K101847000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101847000URGENT PC STIMULATOR; URGENT PC LEAD SETUroplasty, Inc.2010-10-21NAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717591240174PackageGS112In Commercial Distribution
08717591240167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717591240174087175912401748717591240174
08717591240167087175912401678717591240167

GMDN Terms#

Term, Definition table
TermDefinition
Tibial nerve percutaneous incontinence-control electrical stimulation system electrode setA collection of devices designed to be used with a dedicated nonimplantable pulse generator for the delivery of electrical stimuli to the sacral nerve, via percutaneous tibial nerve stimulation (PTNS), to treat urinary and/or faecal incontinence. It typically 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, leads and connectors which are connected to the pulse generator. It conducts an electrical pulse that travels to the sacral nerve plexus via the tibial nerve. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
866-258-2182info.usa@cogentixmedical.com

Regulatory Flags#

DUNS number
804002665
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717591240228Urgent® PC Neuromodulation SystemUPC 200UPC 2002016-09-19
08717591240266Macroplastique ImplantsMPQ-2.5MPQ-2.52014-06-20
08717591240273Rigid Endoscopic NeedleMRN-518MRN-5182016-09-22
08717591240280Rigid Endoscopic NeedleMRN-420MRN-4202016-09-22

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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