COMPEX - PERFORMANCE ELECTRODES, 2X4 (inches) DUAL SNAP - DJO, LLC

Duns Number:081840873

Device Description: PERFORMANCE ELECTRODES, 2X4 (inches) DUAL SNAP 5PK, COMPEX,

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More Product Details

Catalog Number

-

Brand Name

COMPEX

Version/Model Number

CX172EL02-5PK

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K130987

Product Code Details

Product Code

GXY

Product Code Name

ELECTRODE, CUTANEOUS

Device Record Status

Public Device Record Key

79b9a7e3-f869-428f-8f93-845ca4db03ae

Public Version Date

June 02, 2022

Public Version Number

9

DI Record Publish Date

April 26, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DJO, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 784
2 A medical device with a moderate to high risk that requires special controls. 1030
3 A medical device with high risk that requires premarket approval 8