Catalog Number

8481-M100

Brand Name

Tissue-Tek® Genie®

Version/Model Number

8481-M100

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

NJT

Product Code Name

IMMUNOHISTOCHEMISTRY REAGENTS AND KITS

Public Device Record Key

6caf1c2d-e9a4-4131-9034-c516c38ab7da

Public Version Date

August 31, 2020

Public Version Number

1

DI Record Publish Date

August 21, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-