Catalog Number

UPC 250

Brand Name

Urgent® PC Neuromodulation System

Version/Model Number

UPC 250

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K101847,K101847

Product Code

NAM

Product Code Name

Stimulator,Peripheral Nerve,Non-Implanted,For Pelvic Floor Dysfunction

Public Device Record Key

e879fecd-5afd-402f-80d1-4000ccfd84c8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 19, 2016

Package DI Number

08717591240174

Quantity per Package

12

Contains DI Package

08717591240167

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton