Catalog Number

4525

Brand Name

IVS-2

Version/Model Number

Intravaginal Sensor

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 31, 2025

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

8cca5aa9-ebc3-4d22-b0a9-19b5b7209ed5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-