Revolution - Hangwei GE Medical Systems Co., Ltd.

Duns Number:654659689

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More Product Details

Catalog Number

-

Brand Name

Revolution

Version/Model Number

ACT

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

K171013

Product Code Details

Product Code

JAK

Product Code Name

System, x-ray, tomography, computed

Device Record Status

Public Device Record Key

bc12c924-a2d0-4c95-b41c-dd80c6c2bc39

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 27, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HANGWEI GE MEDICAL SYSTEMS CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 59