Duns Number:926599155
Device Description: Stylet Kit, 90cm Length
Catalog Number
ACCK8012-90
Brand Name
Nevro®
Version/Model Number
ACCK8012-90
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P130022
Product Code
LGW
Product Code Name
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Public Device Record Key
af3c9fb8-643f-4f41-9c2a-853b7280f85c
Public Version Date
July 08, 2021
Public Version Number
4
DI Record Publish Date
May 21, 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 |
---|---|---|
3 | A medical device with high risk that requires premarket approval | 74 |