Duns Number:688811603
Catalog Number
-
Brand Name
ARIX System Bone Screw
Version/Model Number
35L-HF-020
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
K131311,K152158,K161864
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
a1d33dcd-a200-4af3-929b-b08fc588b5f0
Public Version Date
August 20, 2019
Public Version Number
5
DI Record Publish Date
September 24, 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 | 1292 |
2 | A medical device with a moderate to high risk that requires special controls. | 6497 |