Catalog Number

490524

Brand Name

ROVERS® CERVEX-BRUSH®

Version/Model Number

490524

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 01, 2021

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

K930955,K930955,K930955

Product Code

HHT

Product Code Name

Spatula, Cervical, Cytological

Public Device Record Key

0c0ffa67-5ba8-4655-8149-96c802bc4643

Public Version Date

October 01, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

30382904905249

Quantity per Package

20

Contains DI Package

10382904905245

Package Discontinue Date

October 01, 2021

Package Status

Not in Commercial Distribution

Package Type

Shelf Pack