Catalog Number

70200

Brand Name

FemSoft® Insert Female Urethral Insert

Version/Model Number

70200

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 12, 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

Yes

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

OCK

Product Code Name

Transurethral occlusion insert, urinary incontinence-control, female

Public Device Record Key

6d42c164-af70-457f-af71-dace141f14a9

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 27, 2015

Package DI Number

10801741011129

Quantity per Package

1

Contains DI Package

00801741011122

Package Discontinue Date

May 12, 2016

Package Status

Not in Commercial Distribution

Package Type

Other