Catalog Number

-

Brand Name

Cytology Brush

Version/Model Number

1

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

HHT

Product Code Name

Spatula, Cervical, Cytological

Public Device Record Key

6a4c6f68-cdfb-42b7-acc8-ee8ddb8c949c

Public Version Date

March 11, 2019

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

10813360023032

Quantity per Package

1000

Contains DI Package

00813360023035

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag