Catalog Number

490526

Brand Name

Rovers ® Combo-brush®

Version/Model Number

490526

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

K043369,K043369,K043369

Product Code

HHT

Product Code Name

Spatula, Cervical, Cytological

Public Device Record Key

0278b9ec-ab5f-45ef-9484-be47dca49f8c

Public Version Date

October 01, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

30382904905263

Quantity per Package

20

Contains DI Package

10382904905269

Package Discontinue Date

October 01, 2021

Package Status

Not in Commercial Distribution

Package Type

Shelf Pack