Duns Number:078294927
Device Description: StimQ Peripheral Nerve Stimulator System StimQ Receiver Stimulator Kit Channel A US w/Rece
Catalog Number
-
Brand Name
StimQ Receiver Stimulator Kit Channel A US w/Receiver
Version/Model Number
STQ4-RCV-A0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K171366
Product Code
GZF
Product Code Name
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Public Device Record Key
699d4362-ed5b-46ff-85a0-8831bf3e59d3
Public Version Date
October 07, 2019
Public Version Number
4
DI Record Publish Date
February 05, 2018
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. | 58 |