NMCT - NM CT 860 Gantry Final - G E MEDICAL SYSTEMS ISRAEL LTD.

Duns Number:532102365

Device Description: NM CT 860 Gantry Final

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More Product Details

Catalog Number

-

Brand Name

NMCT

Version/Model Number

860

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

K173816

Product Code Details

Product Code

JAK

Product Code Name

System, x-ray, tomography, computed

Device Record Status

Public Device Record Key

4fe6fadd-1485-4f31-b080-306f8926630e

Public Version Date

May 17, 2022

Public Version Number

3

DI Record Publish Date

April 23, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"G E MEDICAL SYSTEMS ISRAEL LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 52