Duns Number:081840873
Device Description: PERFORMANCE ELECTRODES 2X4 (inches) DUAL SNAP 5PK, COMPEX,
Catalog Number
-
Brand Name
COMPEX
Version/Model Number
CX142EL02-5PK
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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"
Yes
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
K130987
Product Code
GXY
Product Code Name
ELECTRODE, CUTANEOUS
Public Device Record Key
ad8e8abd-a9ec-4ca6-9cc1-42684fc4bf46
Public Version Date
June 02, 2022
Public Version Number
9
DI Record Publish Date
April 26, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |