Valleylab - Non-REM Polyhesive Patient Return Electrode - Cardinal Health, Inc.

Duns Number:080935429

Device Description: Non-REM Polyhesive Patient Return Electrode

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More Product Details

Catalog Number

E7506-05

Brand Name

Valleylab

Version/Model Number

E7506-05

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

K822572,K822572,K822572

Product Code Details

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Record Status

Public Device Record Key

f94b17ac-6311-4906-a0ff-815f78d42d1f

Public Version Date

June 05, 2020

Public Version Number

8

DI Record Publish Date

July 31, 2017

Additional Identifiers

Package DI Number

20884521196589

Quantity per Package

10

Contains DI Package

10884521196582

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"CARDINAL HEALTH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 672
2 A medical device with a moderate to high risk that requires special controls. 1692
U Unclassified 17