Duns Number:927071162
Device Description: RGEEG Cups: Reusable, Gold Plated, Silver Plated Cooper Fiber + PTFE or Silicon Sheath Lea RGEEG Cups: Reusable, Gold Plated, Silver Plated Cooper Fiber + PTFE or Silicon Sheath Leadwires, EEG Cup Electrodes
Catalog Number
-
Brand Name
MediMax Tech
Version/Model Number
RGEEG EEG Cups
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"
-
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
K153019,K153019,K153019
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
9cfe2b8a-68da-4845-917a-7d6eb932d1a3
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 12, 2016
Package DI Number
20817325022068
Quantity per Package
5
Contains DI Package
10817325022061
Package Discontinue Date
-
Package Status
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 |