Catalog Number

7750

Brand Name

Tissue-Tek Xpress®

Version/Model Number

7750

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

IEO

Product Code Name

PROCESSOR, TISSUE, AUTOMATED

Public Device Record Key

26375e01-0cc1-4101-bfc2-9663e01f9cde

Public Version Date

March 02, 2020

Public Version Number

1

DI Record Publish Date

February 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-