Catalog Number

-

Brand Name

ThinPrep 3000 Processor

Version/Model Number

ThinPrep 3000 Processor

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P950039

Product Code

MKQ

Product Code Name

Processor, cervical cytology slide, automated

Public Device Record Key

bd7fc24e-e1b5-4992-b02b-c9a58522ca65

Public Version Date

November 16, 2020

Public Version Number

4

DI Record Publish Date

September 02, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-