Catalog Number

050125

Brand Name

MedGyn Shaatz w/drain #5

Version/Model Number

Shaatz w/drain #5

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

-

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

HHW

Product Code Name

Pessary, Vaginal

Public Device Record Key

d55d4ab2-60aa-46c9-847c-8a4e03b9b8ec

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

September 02, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-