ProMed Electrotherapy Electrodes - 2"x 3.5" Cloth - Compass Richmar, LLC

Duns Number:080930531

Device Description: 2"x 3.5" Cloth

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More Product Details

Catalog Number

-

Brand Name

ProMed Electrotherapy Electrodes

Version/Model Number

203-813

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 03, 2016

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

GXY

Product Code Name

Electrode, Cutaneous

Device Record Status

Public Device Record Key

9df4060a-da16-4a7b-936b-e5015acd9fd5

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

August 02, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COMPASS RICHMAR, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 47
2 A medical device with a moderate to high risk that requires special controls. 449