Catalog Number

7760

Brand Name

Tissue-Tek Xpress® x50

Version/Model Number

7760

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

KEO

Product Code Name

FORMULATIONS, PARAFFIN, ALL

Public Device Record Key

2d4561b3-19dd-46e9-8111-4cdb5c29b369

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

-