Duns Number:064783913
Device Description: "Accommodates Zirc's 12 & 22 Hole Bur GuardsEnables long and short burs to be used in the "Accommodates Zirc's 12 & 22 Hole Bur GuardsEnables long and short burs to be used in the same bur guard without the short burs falling outAutoclavable up to 136°C/275°FWasher-disinfect"
Catalog Number
-
Brand Name
Universal Bur Adapter (Accessory)
Version/Model Number
50Z412
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
-
Product Code
FSM
Product Code Name
Tray, Surgical, Instrument
Public Device Record Key
3d016568-50e9-4a0d-a4cc-d2f65b299253
Public Version Date
October 17, 2022
Public Version Number
1
DI Record Publish Date
October 07, 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 | 399 |