ProMed - 4" Round Black Silicone Electrode (1 Pack = 2 - PRO MEDICAL SUPPLIES, INC.

Duns Number:135741127

Device Description: 4" Round Black Silicone Electrode (1 Pack = 2 Electrodes per Pack)

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More Product Details

Catalog Number

ProM-094B

Brand Name

ProMed

Version/Model Number

ProM-054B

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K132998

Product Code Details

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Device Record Status

Public Device Record Key

f8b018a9-8413-423e-ba22-03c31eeca48f

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

October 24, 2019

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