ProPatch - Electrodes White Foam Back 2.0"x2.0" Electrodes - PRO MEDICAL SUPPLIES, INC.

Duns Number:135741127

Device Description: Electrodes White Foam Back 2.0"x2.0" Electrodes (100 packs per box -4 electrodes per pack Electrodes White Foam Back 2.0"x2.0" Electrodes (100 packs per box -4 electrodes per pack = 400)

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More Product Details

Catalog Number

ProM-020

Brand Name

ProPatch

Version/Model Number

ProM-020

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)

Yes

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K132998,K132998

Product Code Details

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Device Record Status

Public Device Record Key

12a742fc-c547-404d-8155-b9ea917bc4cf

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

July 26, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRO MEDICAL SUPPLIES, INC." 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. 14