Catalog Number

ASY-11145

Brand Name

Thinprep Imaging System

Version/Model Number

Thinprep Imaging System Computer

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

P020002

Product Code

MNM

Product Code Name

READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED

Public Device Record Key

7ba98217-4033-458f-a422-55e72b365404

Public Version Date

March 22, 2022

Public Version Number

5

DI Record Publish Date

October 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-