Duns Number:085049749
Device Description: A physical template that can be positioned at the osteotomy site that allows the physician A physical template that can be positioned at the osteotomy site that allows the physician the ability to precisely drill the bone screw holes that position the implant positioning or osteotomy guides.
Catalog Number
-
Brand Name
VSP System, VSP Cranial
Version/Model Number
Bone Osteotomy Guide
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
DZJ
Product Code Name
Driver, Wire, And Bone Drill, Manual
Public Device Record Key
8e21ecfe-6ba0-43a6-9963-92805b1e3b81
Public Version Date
December 04, 2020
Public Version Number
3
DI Record Publish Date
September 12, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 146 |