GE Healthcare - Lead wire Set, Add-on, Banana, IEC-HEIM - SHENZHEN LAUNCH ELECTRICAL CO., LTD

Duns Number:544922461

Device Description: Lead wire Set, Add-on, Banana, IEC-HEIM

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More Product Details

Catalog Number

-

Brand Name

GE Healthcare

Version/Model Number

2104750-002

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

-

Product Code Details

Product Code

IKD

Product Code Name

Cable, Electrode

Device Record Status

Public Device Record Key

c977e02e-392d-4a90-bb68-13484a3b3cac

Public Version Date

June 07, 2021

Public Version Number

1

DI Record Publish Date

May 28, 2021

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