Catalog Number

-

Brand Name

Disposable Base Mold

Version/Model Number

CM0214

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

1aa8a080-c8ed-4cff-96a5-98348c0d474b

Public Version Date

August 30, 2022

Public Version Number

2

DI Record Publish Date

February 23, 2022

Package DI Number

10812269039984

Quantity per Package

500

Contains DI Package

00812269039987

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case