Catalog Number

-

Brand Name

Rovers® EndoCervex-Brush®

Version/Model Number

380100703

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 01, 2018

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

K001119,K001119,K001119

Product Code

HHT

Product Code Name

Spatula, Cervical, Cytological

Public Device Record Key

454bdc03-495f-48c8-99b9-330915aa58c4

Public Version Date

September 12, 2019

Public Version Number

4

DI Record Publish Date

October 03, 2016

Package DI Number

87191892461174

Quantity per Package

20

Contains DI Package

87191892461006

Package Discontinue Date

August 01, 2018

Package Status

Not in Commercial Distribution

Package Type

Box