Duns Number:509583543
Device Description: Drill Stop 15 mm Ø2.2, 3.0, 3.4, 3.9 and 4.4 mm
Catalog Number
41146
Brand Name
Neoss Implant System
Version/Model Number
41146
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
DZA
Product Code Name
Drill, Dental, Intraoral
Public Device Record Key
afa026b4-2eca-4355-81b6-b64b9d04887e
Public Version Date
April 01, 2021
Public Version Number
5
DI Record Publish Date
October 01, 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 | 116 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 276 |