DISCOVERY - DISCOVERY IGS 730 002 - GE MEDICAL SYSTEMS

Duns Number:266062561

Device Description: DISCOVERY IGS 730 002

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More Product Details

Catalog Number

-

Brand Name

DISCOVERY

Version/Model Number

IGS 730 002

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

K122457

Product Code Details

Product Code

IZI

Product Code Name

System, x-ray, angiographic

Device Record Status

Public Device Record Key

ab0e3615-8d26-4ad8-9f30-557b1a2b52a9

Public Version Date

November 30, 2021

Public Version Number

4

DI Record Publish Date

August 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GE MEDICAL SYSTEMS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13
2 A medical device with a moderate to high risk that requires special controls. 44
3 A medical device with high risk that requires premarket approval 5