Duns Number:081472844
Device Description: Universal Densah Bur Holder is a holder for the ZGO Densah Burs and ZGO Guided Keys, ZGO T Universal Densah Bur Holder is a holder for the ZGO Densah Burs and ZGO Guided Keys, ZGO Tapered Pilot Drill
Catalog Number
-
Brand Name
Universal ZGO Densah Bur Holder
Version/Model Number
ZBLK
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
NAP
Product Code Name
Cardiac Support Mesh Wrap
Public Device Record Key
3ca0a9f5-6e2c-41fd-84da-1ef853c877d2
Public Version Date
July 07, 2022
Public Version Number
1
DI Record Publish Date
June 29, 2022
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 |