PMI Probasics® - Electrodes Pregelled (4 per package) - PMI

Duns Number:005249268

Device Description: Electrodes Pregelled (4 per package)

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More Product Details

Catalog Number

0069

Brand Name

PMI Probasics®

Version/Model Number

0069

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 25, 2019

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

dca112f3-94ba-411d-983e-1fc920a95013

Public Version Date

October 23, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PMI" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 52