Duns Number:481999654
Device Description: Bone Screw, T5
Catalog Number
662606M
Brand Name
VARIAX
Version/Model Number
662606M
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K180500,K180500
Product Code
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
364d9798-e716-45aa-9348-17f12017ba7f
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 20, 2018
Package DI Number
37613327379120
Quantity per Package
5
Contains DI Package
07613327379129
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2606 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9953 |
| 3 | A medical device with high risk that requires premarket approval | 186 |