Catalog Number

-

Brand Name

NeoControl

Version/Model Number

N-0228-G-110VAC

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"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KPI

Product Code Name

Stimulator, Electrical, Non-Implantable, For Incontinence

Public Device Record Key

b6e60f6b-ee85-4f9f-9735-22eea57160ef

Public Version Date

May 23, 2019

Public Version Number

3

DI Record Publish Date

January 08, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-