Duns Number:044668515
Device Description: CARBIDE DEBONDING BUR 18 FLUTES REG PK/5 DIAMETER 1.6 MM/HEADLENGTH 7.3
Catalog Number
FG218
Brand Name
Carbide Bur
Version/Model Number
FG218
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 05, 2022
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
db9a3be4-bab3-41dd-9fef-6892e8edc540
Public Version Date
October 05, 2022
Public Version Number
5
DI Record Publish Date
February 07, 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 | 16634 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 982 |