Duns Number:071595540
Device Description: CONMED BRAINSTREAM Disposable Deep Cup EEG Electrodes, 150 cm Length
Catalog Number
72615-M-CM-10
Brand Name
CONMED BRAINSTREAM
Version/Model Number
72615-M-CM-10
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
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
233f509e-3de1-4bb8-8c1f-f4bbffd42e46
Public Version Date
June 11, 2020
Public Version Number
1
DI Record Publish Date
June 03, 2020
Package DI Number
30653405986649
Quantity per Package
120
Contains DI Package
20653405986642
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 |