Catalog Number

-

Brand Name

Rovers® Cervex-Brush® Combi

Version/Model Number

380101031

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

K043369,K043369

Product Code

HHT

Product Code Name

Spatula, Cervical, Cytological

Public Device Record Key

2b04eab2-a3b2-4a5b-8801-e4f5ed40b06e

Public Version Date

December 10, 2019

Public Version Number

4

DI Record Publish Date

October 20, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-