N/A - Cosmos 2, DEL - Bucky left - Pausch Medical GmbH

Duns Number:342800789

Device Description: Cosmos 2, DEL - Bucky left

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

03809500

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

IYB

Product Code Name

Tube Mount, X-Ray, Diagnostic

Device Record Status

Public Device Record Key

7f3d3302-b6ab-4a1f-8aaa-0e73837cdf53

Public Version Date

August 09, 2021

Public Version Number

4

DI Record Publish Date

June 08, 2017

Additional Identifiers

Package DI Number

04260491620071

Quantity per Package

1

Contains DI Package

04260491620064

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"PAUSCH MEDICAL GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 6