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

-

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

4e5ad2fc-9e3d-4d8d-87d0-d4b97f59fb70

Public Version Date

March 11, 2019

Public Version Number

4

DI Record Publish Date

August 15, 2016

Package DI Number

10813360023018

Quantity per Package

100

Contains DI Package

00813360023011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag