Catalog Number

-

Brand Name

Rovers® Cervex-Brush® Combi

Version/Model Number

380101000

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,K043369

Product Code

HHT

Product Code Name

Spatula, Cervical, Cytological

Public Device Record Key

da5951df-3a81-4986-89e8-110d9a3a8b77

Public Version Date

September 12, 2019

Public Version Number

4

DI Record Publish Date

October 03, 2016

Package DI Number

87191892460870

Quantity per Package

20

Contains DI Package

87191892460702

Package Discontinue Date

August 01, 2018

Package Status

Not in Commercial Distribution

Package Type

Box