EZ-Stick - 3"x5" Cloth - Compass Richmar, LLC

Duns Number:080930531

Device Description: 3"x5" Cloth

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More Product Details

Catalog Number

-

Brand Name

EZ-Stick

Version/Model Number

201-152

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

7fdb33ee-7679-47db-8210-9f7d9b216679

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

October 22, 2018

Additional Identifiers

Package DI Number

80092237902376

Quantity per Package

50

Contains DI Package

30092237902371

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton

"COMPASS RICHMAR, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 47
2 A medical device with a moderate to high risk that requires special controls. 449