Duns Number:030849173
Device Description: DragonFly™ ROUND CUTTING BUR 80MM LENGTH, 0.8MM Ø WITH BurShield™ - USED WITH 950-002 HAND DragonFly™ ROUND CUTTING BUR 80MM LENGTH, 0.8MM Ø WITH BurShield™ - USED WITH 950-002 HANDPIECE
Catalog Number
-
Brand Name
DragonFly™ BUR, CTR, RD, 80MM L, 0.8MM Ø, BurShield
Version/Model Number
952-80-008-SL
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
EQJ
Product Code Name
Bur, Ear, Nose And Throat
Public Device Record Key
fe7abd23-47b9-4204-a93b-502a8da47a47
Public Version Date
October 23, 2018
Public Version Number
1
DI Record Publish Date
September 22, 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 | 200 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 564 |