Catalog Number

25-2188

Brand Name

Puritan Histobrush®

Version/Model Number

25-2188

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K111681

Product Code

HHT

Product Code Name

Spatula, Cervical, Cytological

Public Device Record Key

a7f645c9-8547-4504-be12-715e97ee4d25

Public Version Date

August 26, 2020

Public Version Number

4

DI Record Publish Date

September 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-