Catalog Number

-

Brand Name

Rovers® Cervex-Brush® Combi RT

Version/Model Number

380301000

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"

Yes

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

93f1694e-7362-4f90-9b12-36ed0aa32c51

Public Version Date

August 16, 2018

Public Version Number

1

DI Record Publish Date

July 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-