MOBILE NANO - Generator, High-Voltage, X-Ray, Diagnostic, - Communications & Power Industries Canada Inc

Duns Number:202887311

Device Description: Generator, High-Voltage, X-Ray, Diagnostic, MOBILE NANO, RAD, 8kW, 62-76V

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More Product Details

Catalog Number

-

Brand Name

MOBILE NANO

Version/Model Number

VZW2566RTDM

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

IZO

Product Code Name

Generator, High-Voltage, X-Ray, Diagnostic

Device Record Status

Public Device Record Key

a6b25679-7e19-456f-9a5e-940080f343c6

Public Version Date

October 12, 2020

Public Version Number

2

DI Record Publish Date

July 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COMMUNICATIONS & POWER INDUSTRIES CANADA INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 34
2 A medical device with a moderate to high risk that requires special controls. 1