Duns Number:480789465
Device Description: VADER Pedicle System Trial Rod MIS, curved Ø 6.0 mm, R 120, L = 100 mm
Catalog Number
42-910-6010
Brand Name
VADER Pedicle System Trial Rod MIS, curved Ø 6.0 mm, R 120, L = 100 mm
Version/Model Number
42-910-6010
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
NKB
Product Code Name
Thoracolumbosacral Pedicle Screw System
Public Device Record Key
8c301d6e-520e-4d0c-b8ed-b59a0438cf6e
Public Version Date
December 02, 2021
Public Version Number
2
DI Record Publish Date
August 15, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 651 |