Duns Number:968623467
Device Description: Paddle Lead Kit (3-4-3-2 Electrode Configuration)
Catalog Number
3000-60
Brand Name
Algovita®
Version/Model Number
3000-60-USA
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
LGW
Product Code Name
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Public Device Record Key
6b24c057-a29b-4b91-b788-214fbc954842
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 01, 2015
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 275 |
| 3 | A medical device with high risk that requires premarket approval | 68 |