Catalog Number

-

Brand Name

Rovers® Cervex-Brush® Combi

Version/Model Number

380101-030

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

aa2f4d02-b87a-4f9d-9cbb-fc5b2c08cb0a

Public Version Date

September 19, 2019

Public Version Number

1

DI Record Publish Date

September 11, 2019

Package DI Number

18719189246381

Quantity per Package

20

Contains DI Package

08719189246384

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box