Catalog Number

-

Brand Name

Rovers® Cervex-Brush® Combi

Version/Model Number

491462

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

K043369,K043369,K043369,K043369

Product Code

HHT

Product Code Name

Spatula, Cervical, Cytological

Public Device Record Key

e5a57862-327c-4952-aab6-0ec9702b7b88

Public Version Date

September 12, 2019

Public Version Number

2

DI Record Publish Date

July 09, 2018

Package DI Number

18719189246497

Quantity per Package

20

Contains DI Package

08719189246490

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box