Henry Schein - General Monitoring Foam Electrode with Metal - HENRY SCHEIN, INC.

Duns Number:012430880

Device Description: General Monitoring Foam Electrode with Metal Snap, Diaphoretic

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More Product Details

Catalog Number

5702550

Brand Name

Henry Schein

Version/Model Number

5702550

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"

Yes

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

-

Product Code Details

Product Code

DRX

Product Code Name

Electrode, electrocardiograph

Device Record Status

Public Device Record Key

120811d2-d4cd-42f1-b5ab-c806caabb9a9

Public Version Date

April 01, 2021

Public Version Number

1

DI Record Publish Date

March 24, 2021

Additional Identifiers

Package DI Number

20304040145214

Quantity per Package

20

Contains DI Package

10304040145217

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"HENRY SCHEIN, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3829
2 A medical device with a moderate to high risk that requires special controls. 2579
3 A medical device with high risk that requires premarket approval 1
U Unclassified 34