Catalog Number

8874-G004

Brand Name

Tissue-Tek Genie®

Version/Model Number

8874-G004

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

PPM

Product Code Name

General purpose reagent

Public Device Record Key

eca5258d-2a9b-417e-9eac-d7a2d5c2dd85

Public Version Date

December 23, 2019

Public Version Number

1

DI Record Publish Date

December 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-