Catalog Number

0200003

Brand Name

ThinPrep

Version/Model Number

CytoLyt Quart

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

Yes

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

LEA

Product Code Name

PRESERVATIVE, CYTOLOGICAL

Public Device Record Key

4e96e017-a3d0-4f1c-9192-32fd12233308

Public Version Date

July 22, 2021

Public Version Number

2

DI Record Publish Date

August 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-