Duns Number:081224143
Device Description: DRILL, 16 mm
Catalog Number
-
Brand Name
Aranax Anterior Cervical Plating System
Version/Model Number
T086-0716
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
-
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
f43c3b4b-0cdb-4176-8b45-fd713dde1ced
Public Version Date
June 03, 2021
Public Version Number
4
DI Record Publish Date
December 09, 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 | 1719 |
2 | A medical device with a moderate to high risk that requires special controls. | 3162 |
U | Unclassified | 25 |