Duns Number:055605664
Device Description: Cortical Bone Drill, 5.0mm
Catalog Number
-
Brand Name
Zuga
Version/Model Number
CBD-500-000
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
-
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
K122664
Product Code
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
b029f44b-d768-4393-8b1e-8d201d838fd1
Public Version Date
November 22, 2018
Public Version Number
4
DI Record Publish Date
January 12, 2018
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 | 27 |
2 | A medical device with a moderate to high risk that requires special controls. | 153 |