Uni-Patch - Specialty Stimulating Electrodes,640 - Cardinal Health, Inc.

Duns Number:080935429

Device Description: Specialty Stimulating Electrodes,640

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More Product Details

Catalog Number

EP84690

Brand Name

Uni-Patch

Version/Model Number

EP84690

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)

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

GXY

Product Code Name

ELECTRODE, CUTANEOUS

Device Record Status

Public Device Record Key

afb47906-54b1-4089-84cf-5b86512b500b

Public Version Date

February 19, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

90884521167991

Quantity per Package

250

Contains DI Package

10884521167995

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