ProFlex - PROFLEX AgC REUSABLE ELECTRODES - 2 X 2" SQUARE - C.M.P. Canadian Medical Products Inc

Duns Number:245449335

Device Description: PROFLEX AgC REUSABLE ELECTRODES - 2 X 2" SQUARE 4/pk

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More Product Details

Catalog Number

-

Brand Name

ProFlex

Version/Model Number

F5047PF

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

Yes

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

3d68ef98-8b0e-4b78-a09c-0f0a5512822f

Public Version Date

August 22, 2022

Public Version Number

1

DI Record Publish Date

August 12, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"C.M.P. CANADIAN MEDICAL PRODUCTS INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 162