Duns Number:081472844
Device Description: Provides vertical control for drilling the osteotomy. The G-Stop Gauges and G-Stop Keys ca Provides vertical control for drilling the osteotomy. The G-Stop Gauges and G-Stop Keys can be used with printed guides to control the angulation of the hole
Catalog Number
-
Brand Name
G-Stop Keys-Large-11.5mm
Version/Model Number
VTSP-L-O-11.5
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
EJL
Product Code Name
Bur, Dental
Public Device Record Key
cdaed3e8-d921-4770-b531-35d5eefa987e
Public Version Date
April 27, 2020
Public Version Number
1
DI Record Publish Date
April 17, 2020
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 | 72 |