Duns Number:156567492
Device Description: Ti 6Al 4V (ELI)
Catalog Number
C5SD16005
Brand Name
Innovasis® Cranial System
Version/Model Number
C5SD16005
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K141644
Product Code
GWO
Product Code Name
Plate, Cranioplasty, Preformed, Alterable
Public Device Record Key
da2ad607-1c6b-4686-9ff3-0696027fbf15
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 29, 2014
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 | 252 |
2 | A medical device with a moderate to high risk that requires special controls. | 2102 |