Duns Number:829838288
Device Description: Sheath 11 mm x 50 mm
Catalog Number
-
Brand Name
NICO BrainPath
Version/Model Number
NN-8031
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
K172433,K172433
Product Code
GZT
Product Code Name
Retractor, Self-Retaining, For Neurosurgery
Public Device Record Key
77a5fe17-90cd-41b3-ac6f-c36b43e26e0a
Public Version Date
June 08, 2021
Public Version Number
4
DI Record Publish Date
November 08, 2017
Package DI Number
10816744028319
Quantity per Package
2
Contains DI Package
00816744028312
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |