Rhythmlink® - Reusable Disc Electrodes, EEG, Gold Plated Discs, - RHYTHMLINK INTERNATIONAL, LLC

Duns Number:126290993

Device Description: Reusable Disc Electrodes, EEG, Gold Plated Discs, 60 inch Twisted Leadwire

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More Product Details

Catalog Number

-

Brand Name

Rhythmlink®

Version/Model Number

445-10G-60PTP

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

824916f4-8ce9-4597-b698-db311144db2f

Public Version Date

August 11, 2021

Public Version Number

1

DI Record Publish Date

August 03, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RHYTHMLINK INTERNATIONAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 453