Catalog Number

2195

Brand Name

Rovers EndoCervex Brush

Version/Model Number

2195

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

HHT

Product Code Name

Spatula, Cervical, Cytological

Public Device Record Key

aca1e357-2b4f-4a67-bde5-93ee1d70a1ec

Public Version Date

August 26, 2020

Public Version Number

3

DI Record Publish Date

September 07, 2016

Package DI Number

50609576250090

Quantity per Package

875

Contains DI Package

10609576250092

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-