Duns Number:481999654
Device Description: Depth Gauge 2/CP Screws For T8 and T10 Screws
Catalog Number
705170
Brand Name
VARIAX
Version/Model Number
705170
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
-
Product Code
HRS
Product Code Name
Plate, fixation, bone
Public Device Record Key
69cb9b18-e4cb-44bd-87fc-c399578aa025
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 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 | 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 |