SOMATOM X.cite - Siemens Healthcare GmbH

Duns Number:313217003

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More Product Details

Catalog Number

-

Brand Name

SOMATOM X.cite

Version/Model Number

11330001

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

JAK

Product Code Name

System, x-ray, tomography, computed

Device Record Status

Public Device Record Key

f3b5a86d-4927-4afe-aed9-aae5d2ce70bd

Public Version Date

November 17, 2021

Public Version Number

4

DI Record Publish Date

December 11, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIEMENS HEALTHCARE 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. 478
3 A medical device with high risk that requires premarket approval 1