MedSource Electrodes (3/pk - 200pks/cs) - Electrodes (3/pk - 200pks/cs) - MEDSOURCE INTERNATIONAL LLC

Duns Number:041674552

Device Description: Electrodes (3/pk - 200pks/cs)

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More Product Details

Catalog Number

-

Brand Name

MedSource Electrodes (3/pk - 200pks/cs)

Version/Model Number

MS-65003

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K093327

Product Code Details

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Device Record Status

Public Device Record Key

72ae3b4b-4e78-4829-a2d7-b920fbfbfe4e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 14, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDSOURCE INTERNATIONAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 498
2 A medical device with a moderate to high risk that requires special controls. 90