Duns Number:322018193
Device Description: C2011.3860 CONELOG® Healing cap, bottleneck, d 3.8, GH 6.0 mm
Catalog Number
C2011.3860
Brand Name
CONELOG® Healing cap, bottleneck
Version/Model Number
C2011.3860
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 30, 2015
Issuing Agency
In HIBCC
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
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
3026d6f5-a890-4edc-baa2-a0b26b5f2a98
Public Version Date
December 07, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2015
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 | 290 |
2 | A medical device with a moderate to high risk that requires special controls. | 901 |