Duns Number:688999370
Device Description: 5 x straight 2 hole plates 15.4mm + 5 self tapping screws Ø1.5 x 4.0mm + 5 self drilling s 5 x straight 2 hole plates 15.4mm + 5 self tapping screws Ø1.5 x 4.0mm + 5 self drilling screws Ø1.5 x 4.0mm
Catalog Number
-
Brand Name
Neuro Plating System
Version/Model Number
TCN-012
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K190811
Product Code
GWO
Product Code Name
Plate, Cranioplasty, Preformed, Alterable
Public Device Record Key
95637543-540a-49c5-b534-7b4c0a60c6e8
Public Version Date
October 20, 2021
Public Version Number
2
DI Record Publish Date
December 30, 2019
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 | 26 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 218 |