Catalog Number

-

Brand Name

Embedding Cassette

Version/Model Number

EC0203EXT

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

Yes

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

IDZ

Product Code Name

Cassettes, Tissue

Public Device Record Key

3db86844-7ead-4c8b-81ff-028823055314

Public Version Date

May 27, 2022

Public Version Number

1

DI Record Publish Date

May 19, 2022

Package DI Number

10810050854488

Quantity per Package

2000

Contains DI Package

00810050854481

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case