Catalog Number

-

Brand Name

Rovers® Cervex-Brush®

Version/Model Number

380100311

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

K930955,K930955,K930955

Product Code

HHT

Product Code Name

Spatula, Cervical, Cytological

Public Device Record Key

58f767fe-1956-4d5f-a1be-713be14811c5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 20, 2017

Package DI Number

87191892466018

Quantity per Package

20

Contains DI Package

08719189246001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box