Duns Number:067140761
Device Description: Nalu User's Trial Kit
Catalog Number
74002-US
Brand Name
Nalu Medical, Inc.
Version/Model Number
74002-US
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
GZB
Product Code Name
Stimulator, Spinal-Cord, Implanted (Pain Relief)
Public Device Record Key
34bf8af3-ecf7-4a7a-9ac4-fcb507de220d
Public Version Date
June 08, 2021
Public Version Number
4
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 |