Cios Select - mobile C-arm - Siemens Shanghai Medical Equipment Ltd.

Duns Number:654129626

Device Description: mobile C-arm

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More Product Details

Catalog Number

-

Brand Name

Cios Select

Version/Model Number

10893686

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

-

Product Code Details

Product Code

OXO

Product Code Name

Image-intensified fluoroscopic x-ray system, mobile

Device Record Status

Public Device Record Key

6cf2942d-a053-4473-983d-b25ceeb30a09

Public Version Date

November 17, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 32