Duns Number:438793622
Device Description: DRILL BIT D.1,6 MM L.90 MM TIN COATED - QUICK CONNECT
Catalog Number
1-1100401
Brand Name
Dynamic Axial Fixator
Version/Model Number
1
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
-
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
K955848
Product Code
JDW
Product Code Name
Pin, Fixation, Threaded
Public Device Record Key
a9a13194-f1d5-4666-80d2-6f373cf8aa6b
Public Version Date
November 22, 2018
Public Version Number
5
DI Record Publish Date
September 16, 2016
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 | 64 |
2 | A medical device with a moderate to high risk that requires special controls. | 6371 |