Duns Number:509583543
Device Description: Prepable Abutment Blanks Ti SSC, Ø12 mm, NP – 5 pc
Catalog Number
31381
Brand Name
Neoss Implant System
Version/Model Number
31381
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"
-
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
e16d03f3-8760-49cf-a75a-fc51c2104a8d
Public Version Date
April 26, 2022
Public Version Number
2
DI Record Publish Date
May 12, 2021
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 | 116 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 276 |