Catalog Number

490521

Brand Name

BD PrepStain

Version/Model Number

490521

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 26, 2015

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

-

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

P970018

Product Code

MKQ

Product Code Name

Processor, Cervical Cytology Slide, Automated

Public Device Record Key

c6e878a7-1fa0-4e9f-a794-66167b0e6352

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 22, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-