NSS-2 01-1017-NSS-2/Bridge

GUDID B327NSS200

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 regular therapy over several days. The appliance transmits low-frequency electric pulses to exposed nerve endings.

KEY ELECTRONICS, INC.

CNS-modulation periauricular nerve percutaneous electrical stimulator CNS-modulation periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
Primary Device IDB327NSS200
NIH Device Record Key2d6d952d-c85d-4dad-803e-512cd1765e3e
Commercial Distribution StatusIn Commercial Distribution
Brand NameNSS-2
Version Model NumberBridge
Catalog Number01-1017-NSS-2/Bridge
Company DUNS172218799
Company NameKEY ELECTRONICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB327NSS200 [Primary]
HIBCCB327NSS2001 [Package]
Package: BOX [10 Units]
In Commercial Distribution
HIBCCB327NSS2002 [Package]
Package: BOX [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PZRPercutaneous Nerve Stimulator For Opioid Withdrawal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-07
Device Publish Date2018-03-30

Devices Manufactured by KEY ELECTRONICS, INC.

B327NSS201 - NSS Neurostim2019-10-23 The NSS Neurostim ((510)K140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of
B327NSS202 - NSS MFS2019-10-23 The NSS Military Field Stimulator (MFS) ((510)K140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in
B327NSS2032 - IB-STIM2019-10-07 The IB-STIM (DEN180057) is a percutaneous electrical nerve field stimulator (PENFS) system, which is used in a target population
B327NSS200 - NSS-22019-10-07The 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 regular therapy over several days. The appliance transmits low-frequency electric pulses to exposed nerve endings.
B327NSS200 - NSS-22019-10-07 The NSS-2 BRIDGE is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of op
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.