Catalog Number

-

Brand Name

Rovers® Cervex-Brush®

Version/Model Number

491461

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,K930955

Product Code

HHT

Product Code Name

Spatula, Cervical, Cytological

Public Device Record Key

b3dc1f2c-673e-4d13-8dc2-da6f7e0a678a

Public Version Date

September 12, 2019

Public Version Number

2

DI Record Publish Date

July 09, 2018

Package DI Number

18719189246480

Quantity per Package

20

Contains DI Package

08719189246483

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box