NA - EEG Lead Set with 9 individual color coded leads - Philips Medizin Systeme Böblingen GmbH

Duns Number:314101143

Device Description: EEG Lead Set with 9 individual color coded leads for use on adults. Lead wires come with D EEG Lead Set with 9 individual color coded leads for use on adults. Lead wires come with DIN connector on one end and hard mounted EEG silver cup electrodes on the other end. Individual leads are hold in place with a lead organizer. Silver cup diameter = 10mm, 80 cm (31.5 in) long leads.Use with trunk cable 989803180541 and conductive paste M1937A.

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More Product Details

Catalog Number

989803180561

Brand Name

NA

Version/Model Number

EEG CBL Lead Set Adult for 9 Elec.

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

-

Product Code Details

Product Code

IKD

Product Code Name

CABLE, ELECTRODE

Device Record Status

Public Device Record Key

b5a3b099-dd12-4b93-bd85-93fe7f26e3d8

Public Version Date

September 20, 2022

Public Version Number

5

DI Record Publish Date

March 15, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 209