Duns Number:040729840
Device Description: Bone Condenser #4-8 Lite Handle Double Ended Plain Tips
Catalog Number
-
Brand Name
Bone Condenser
Version/Model Number
1102-RECN4P8
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"
Yes
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
EKH
Product Code Name
CARVER, DENTAL AMALGAM, OPERATIVE
Public Device Record Key
8355ffe8-2007-4a19-85f8-dfc26a2c5e22
Public Version Date
September 22, 2020
Public Version Number
2
DI Record Publish Date
June 15, 2020
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 | 10108 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3414 |