Catalog Number

-

Brand Name

Rovers® EndoCervex-Brush®

Version/Model Number

380100703

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

K001119,K001119,K001119

Product Code

HHT

Product Code Name

Spatula, Cervical, Cytological

Public Device Record Key

4bbbdafb-f2bb-47da-9ea5-0f56ca88a7c8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 20, 2017

Package DI Number

08719189246117

Quantity per Package

20

Contains DI Package

08719189246100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box