Catalog Number

491313

Brand Name

BD PrepMate™ Consumables Kit

Version/Model Number

491313

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 25, 2020

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

P970018

Product Code

MKQ

Product Code Name

Processor, Cervical Cytology Slide, Automated

Public Device Record Key

9b041b66-ba18-473d-bd61-eb2e90f23ce9

Public Version Date

October 26, 2020

Public Version Number

5

DI Record Publish Date

September 08, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-