Duns Number:063076701
Device Description: The NSS-2 BRIDGE is a percutaneous nerve field stimulator (PNFS) system, that can be used The NSS-2 BRIDGE is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptomsof opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified bytransillumination. NSS-2 BRIDGE stimulator is a battery-operated micro-stimulation appliance weighing approximately 5 gramsdesigned as a disposable product for a single use. The NSS-2 BRIDGE stimulator is placed behind the patient’s ear andconnected to stimulation needles on the auricle. NSS-2 BRIDGE stimulator offers regular therapy over several days. Theappliance transmits low-frequency electric pulses to exposed nerve endings.
Catalog Number
01-1017-NSS-2/BRIDGE
Brand Name
NSS-2 Bridge
Version/Model Number
Bridge
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
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
PZR
Product Code Name
Percutaneous Nerve Stimulator For Opioid Withdrawal
Public Device Record Key
9be78d8b-7bb5-46ac-916e-6c6e461ae076
Public Version Date
October 21, 2022
Public Version Number
3
DI Record Publish Date
February 12, 2021
Package DI Number
B960NSS2001
Quantity per Package
10
Contains DI Package
B960NSS200
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box