Duns Number:942377524
Device Description: VIPER/VALT 2.7MM DRILL BIT
Catalog Number
605027
Brand Name
Viper® Distal Volar Radius Plating System
Version/Model Number
605027
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
HTW
Product Code Name
BIT, DRILL
Public Device Record Key
705a8120-2555-478b-97fd-317ca8e1191a
Public Version Date
March 04, 2021
Public Version Number
3
DI Record Publish Date
April 13, 2018
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 | 1909 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1404 |
| 3 | A medical device with high risk that requires premarket approval | 12 |
| U | Unclassified | 15 |