Catalog Number

-

Brand Name

Omnistim FX2 Continence Plus Portable

Version/Model Number

300100A

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

K093600

Product Code

KPI

Product Code Name

Stimulator, Electrical, Non-Implantable, For Incontinence

Public Device Record Key

b068d695-1ee5-4356-9577-4cb7fd117659

Public Version Date

August 07, 2020

Public Version Number

4

DI Record Publish Date

August 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-