Duns Number:353939929
Device Description: NPr Abutment Ti for Zimmer Hex 3.5
Catalog Number
23184
Brand Name
NobelProcera®
Version/Model Number
23184
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 08, 2020
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
NHA
Product Code Name
ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
Public Device Record Key
a59a79a4-50aa-45d4-8e54-63e539316478
Public Version Date
October 28, 2020
Public Version Number
8
DI Record Publish Date
September 17, 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 | 782 |
2 | A medical device with a moderate to high risk that requires special controls. | 3680 |