Duns Number:071595540
Device Description: CONMED BRAINSTREAM Disposable Deep Cup EEG Electrodes, 150 cm Length, 21 Electrodes
Catalog Number
72615-M-CM-21
Brand Name
BRAINSTREAM
Version/Model Number
72615-M-CM-21
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
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
K200540,K200540,K200540
Product Code
GXY
Product Code Name
Electrode, cutaneous
Public Device Record Key
32894d56-997f-4e82-8908-be01e5aa35ff
Public Version Date
March 08, 2021
Public Version Number
1
DI Record Publish Date
February 26, 2021
Package DI Number
30653405987073
Quantity per Package
252
Contains DI Package
20653405987076
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |