Catalog Number

-

Brand Name

Lifecare

Version/Model Number

PR-04H

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

-

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

b5a43169-4ac8-40f4-b042-ba64a1a6dab6

Public Version Date

August 07, 2020

Public Version Number

3

DI Record Publish Date

December 02, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-