Duns Number:067140761
Device Description: Peripheral Nerve Stimulation Lead Kit (8 contact, 40 cm)
Catalog Number
72011-US
Brand Name
Nalu Medical, Inc.
Version/Model Number
72011-US
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
-
Product Code
GZF
Product Code Name
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Public Device Record Key
b7c4e3a4-475c-4096-b2d9-b7da78a71587
Public Version Date
April 29, 2020
Public Version Number
1
DI Record Publish Date
April 21, 2020
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. | 270 |