GE Healthcare - One-piece 3 Lead wires Set, Clamp, AHA - SHENZHEN LAUNCH ELECTRICAL CO., LTD

Duns Number:544922461

Device Description: One-piece 3 Lead wires Set, Clamp, AHA

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More Product Details

Catalog Number

-

Brand Name

GE Healthcare

Version/Model Number

MA0103

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

55dce849-2f1d-4846-a29e-129b68f7a95e

Public Version Date

May 05, 2020

Public Version Number

1

DI Record Publish Date

April 27, 2020

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