AMX - AMX Navigate Designated Medical Device Assembly - GE MEDICAL SYSTEMS, INC.

Duns Number:809785715

Device Description: AMX Navigate Designated Medical Device Assembly

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

AMX

Version/Model Number

Navigate

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

K210982

Product Code Details

Product Code

IZL

Product Code Name

System, x-ray, mobile

Device Record Status

Public Device Record Key

fbbcf95c-ddec-4fc6-8b0a-8563e93c4c9b

Public Version Date

November 01, 2021

Public Version Number

1

DI Record Publish Date

October 22, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GE MEDICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 54