Duns Number:829838288
Device Description: BP & Illumination Pack [13.5x50 mm + PB1113 + SelectLock(G) + meniG + SecureH] + [11GA Ill BP & Illumination Pack [13.5x50 mm + PB1113 + SelectLock(G) + meniG + SecureH] + [11GA Illum]
Catalog Number
-
Brand Name
NICO BrainPath Approach
Version/Model Number
NN-3007
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
-
Product Code
OJG
Product Code Name
Neurological Tray
Public Device Record Key
3cdeff0c-f471-4822-93c9-4cb10950fe11
Public Version Date
April 13, 2021
Public Version Number
1
DI Record Publish Date
April 05, 2021
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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 62 |