Catalog Number

-

Brand Name

Thermo Fisher

Version/Model Number

Histostar

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 26, 2020

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

IDW

Product Code Name

Dispensers, Paraffin

Public Device Record Key

6308c533-a4eb-4d3b-8700-76f3ee20478b

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

September 16, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-