Catalog Number

ASY-13755

Brand Name

ThinPrep Imaging System

Version/Model Number

ThinPrep Imaging System Workstation

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

October 31, 2025

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

-

Product Code

MNM

Product Code Name

READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED

Public Device Record Key

848cf59b-48a0-4bf2-8423-8e3687ccbb97

Public Version Date

March 22, 2022

Public Version Number

3

DI Record Publish Date

December 03, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-