Duns Number:322018193
Device Description: CONELOG® PROGRESSIVE-LINE Implant, Promote® plus, d 3.3 mm, L 9 mm
Catalog Number
C1086.3309
Brand Name
CONELOG® PROGRESSIVE-LINE Implant, Promote® plus
Version/Model Number
C1086.3309
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
a752c159-39f4-4571-9883-6c9fc5597fe8
Public Version Date
October 22, 2020
Public Version Number
1
DI Record Publish Date
October 14, 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 | 290 |
2 | A medical device with a moderate to high risk that requires special controls. | 901 |