Duns Number:126290993
Device Description: 24 electrodes, 13mm long, 0.4mm diameter disposable single subdermal needle and 4 electrod 24 electrodes, 13mm long, 0.4mm diameter disposable single subdermal needle and 4 electrodes, 15x20mm recording sticky pad surface electrode with touch proof connector and 1 template, color-coded 10/20 BraiNet
Catalog Number
-
Brand Name
Rhythmlink®
Version/Model Number
BNT120-1020-5457
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 25, 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"
-
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
-
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
3b16b52c-7f4b-4bb4-ad50-61592a4ff9ac
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
September 17, 2016
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 453 |