GE Healthcare - Leadwire Set, Add-on, Grabber, AHA-HEIM - SHENZHEN LAUNCH ELECTRICAL CO., LTD

Duns Number:544922461

Device Description: Leadwire Set, Add-on, Grabber, AHA-HEIM

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More Product Details

Catalog Number

-

Brand Name

GE Healthcare

Version/Model Number

2104725-001

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

IKD

Product Code Name

Cable, Electrode

Device Record Status

Public Device Record Key

0ecd3df1-1663-4735-bd55-f48f56d2913a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 22, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SHENZHEN LAUNCH ELECTRICAL CO., LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 62