Chalgren - Reusable Disc Electrodes, EEG, 10 mm Silver - CHALGREN ENTERPRISES

Duns Number:085932630

Device Description: Reusable Disc Electrodes, EEG, 10 mm Silver Plated Discs, 120 inch PVC Leadwire (Assorted Reusable Disc Electrodes, EEG, 10 mm Silver Plated Discs, 120 inch PVC Leadwire (Assorted Colors)

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More Product Details

Catalog Number

445-10S-120TP

Brand Name

Chalgren

Version/Model Number

445-10S-120TP

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)

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

GXY

Product Code Name

Electrode, Cutaneous

Device Record Status

Public Device Record Key

02f24d4b-4cda-4691-a28b-e18aafb3be94

Public Version Date

January 11, 2021

Public Version Number

3

DI Record Publish Date

September 09, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CHALGREN ENTERPRISES" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 66