Duns Number:172218799
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 symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination. NSS-2 BRIDGE stimulator is a battery-operated micro-stimulation appliance weighing approximately 5 grams designed as a disposable product for a single use. The NSS-2 BRIDGE stimulator is placed behind the patient’s ear and connected to stimulation needles on the auricle. NSS-2 BRIDGE stimulator offers regulartherapy over several days. The appliance transmits low-frequency electric pulses to exposed nerve endings.
Catalog Number
01-1017-NSS-2/Bridge
Brand Name
NSS-2
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
DEN170018,DEN170018,DEN170018
Product Code
PZR
Product Code Name
Percutaneous Nerve Stimulator For Opioid Withdrawal
Public Device Record Key
2d6d952d-c85d-4dad-803e-512cd1765e3e
Public Version Date
June 19, 2020
Public Version Number
5
DI Record Publish Date
March 30, 2018
Package DI Number
B327NSS2002
Quantity per Package
20
Contains DI Package
B327NSS200
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX