The Electrode Store - Disposable Subdermal EEG Needle Electrodes, 12mm - IMPULSE MEDICAL TECHNOLOGIES, INC.

Duns Number:080015502

Device Description: Disposable Subdermal EEG Needle Electrodes, 12mm x29ga Steel; 36" 3 colors

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More Product Details

Catalog Number

62056

Brand Name

The Electrode Store

Version/Model Number

62056

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

Yes

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

GXZ

Product Code Name

Electrode, Needle

Device Record Status

Public Device Record Key

88828226-6c41-49cb-9aee-1350caa7784d

Public Version Date

August 10, 2020

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMPULSE MEDICAL TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 166