Fraxion - The indexed FRAXION™ CT Adapter allows you to - Medical Intelligence Medizintechnik GmbH

Duns Number:314546664

Device Description: The indexed FRAXION™ CT Adapter allows you to prepare patients for CT imaging.

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More Product Details

Catalog Number

P10106-104

Brand Name

Fraxion

Version/Model Number

P10106-104

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K112210

Product Code Details

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Device Record Status

Public Device Record Key

e320664b-19cb-4cc5-821e-71be89e4921d

Public Version Date

October 13, 2021

Public Version Number

5

DI Record Publish Date

August 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 175