Duns Number:079398589
Device Description: SureLOK MIS ø6.5mm Cannulated Pedicle Screw Tap
Catalog Number
09-9033-65
Brand Name
SureLOK Pedicle Screw System
Version/Model Number
09-9033-65
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
HWX
Product Code Name
Tap, Bone
Public Device Record Key
ffb0f58e-e7ff-4c32-87c7-7a733c4793b3
Public Version Date
August 28, 2019
Public Version Number
3
DI Record Publish Date
April 01, 2019
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 | 1423 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4960 |
| U | Unclassified | 26 |