Catalog Number

4510C

Brand Name

SenseRx -- Anal/Small Vaginal and Vaginal EMG

Version/Model Number

4510C

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 06, 2016

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

K002834

Product Code

HIR

Product Code Name

Perineometer

Public Device Record Key

b4a94292-9f2f-41c1-b5b7-69e9be9462f9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 04, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-