Duns Number:004022104
Device Description: OVERWATCH® 6.5MM x 60MM MIS POLY EXTENDED TAB DUALFIX CANNULATED SCREW
Catalog Number
-
Brand Name
OVERWATCH
Version/Model Number
108-ET-6560DC
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
NKB
Product Code Name
Thoracolumbosacral Pedicle Screw System
Public Device Record Key
ebdf9ea5-959f-4d5e-a4fa-f151f0d8633b
Public Version Date
February 23, 2021
Public Version Number
3
DI Record Publish Date
February 18, 2020
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 | 1993 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3642 |
| U | Unclassified | 15 |