Duns Number:927071162
Device Description: MXF55R-50 ELECTRODE FOAM, 55MM ROUND, SINGLE PACK OF 50
Catalog Number
-
Brand Name
MediMax Tech
Version/Model Number
MXF55R-50
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 09, 2018
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
Yes
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
K020003,K020003,K020003
Product Code
DRX
Product Code Name
Electrode, Electrocardiograph
Public Device Record Key
24502eae-acba-4ade-9af8-4657287d96fb
Public Version Date
September 10, 2018
Public Version Number
2
DI Record Publish Date
June 11, 2018
Package DI Number
20817325023119
Quantity per Package
4
Contains DI Package
10817325023112
Package Discontinue Date
September 09, 2018
Package Status
Not in Commercial Distribution
Package Type
Master Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 309 |