Cassette Stainless Steel Base Mold - Stainless Steel Base Mold, 30x24x9 - TYPENEX MEDICAL LLC

Duns Number:600850213

Device Description: Stainless Steel Base Mold, 30x24x9

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More Product Details

Catalog Number

-

Brand Name

Cassette Stainless Steel Base Mold

Version/Model Number

CM0109

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

IDZ

Product Code Name

Cassettes, Tissue

Device Record Status

Public Device Record Key

3eef3664-5cd8-461c-b44f-6d07a26d2495

Public Version Date

March 03, 2022

Public Version Number

1

DI Record Publish Date

February 23, 2022

Additional Identifiers

Package DI Number

10812269039939

Quantity per Package

10

Contains DI Package

00812269039932

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"TYPENEX MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 39
2 A medical device with a moderate to high risk that requires special controls. 48