Norco Multi-Use Electrode, Foam - Norco Multi-Use Electrode, Foam, Oval, 1 1/2" x 2 - NORTH COAST MEDICAL, INC.

Duns Number:060121928

Device Description: Norco Multi-Use Electrode, Foam, Oval, 1 1/2" x 2 1/2" (4)

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More Product Details

Catalog Number

-

Brand Name

Norco Multi-Use Electrode, Foam

Version/Model Number

NC89279

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

-

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

-

FDA Premarket Submission

K130987

Product Code Details

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Device Record Status

Public Device Record Key

86c839ea-2752-40ca-80b3-6375f37a9708

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

September 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NORTH COAST MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 18