Duns Number:789127011
Device Description: RGEEG-12 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.2m Length, Silver plated coppe RGEEG-12 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.2m Length, Silver plated copper fiber + PTFE or Silicon Sheath, Gold Plated 92.5% Silver, Reusable EEG Cups
Catalog Number
-
Brand Name
Bio Protech
Version/Model Number
RGEEG-12 (Lifelines)
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
d7351586-588b-48ca-a382-5cc400aaaafe
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 09, 2017
Package DI Number
20817120021198
Quantity per Package
5
Contains DI Package
10817120021191
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 103 |