NSS-2 Bridge

Primary DI
B960NSS2001
Brand
NSS-2 Bridge
Company
Innovative Health Solutions, Inc
Model
Bridge
Catalog number
01-1017-NSS-2/BRIDGE
Device description
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.
Published
2021-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PZRPercutaneous Nerve Stimulator For Opioid Withdrawal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZRPercutaneous Nerve Stimulator For Opioid WithdrawalNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B960NSS2001PackageHIBCC10In Commercial Distribution
B960NSS2002PackageHIBCC20In Commercial Distribution
B960NSS2003PackageHIBCC5In Commercial Distribution
B327NSS200PreviousHIBCC0
B960NSS200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulatorA body-worn, electronic device intended to provide percutaneous electrical nerve field stimulation (PENFS) applied close to cranial/peripheral nerves around the external ear to achieve remote symptom relief mediated by central nervous system (CNS) pathways and structures [e.g., amygdala, spinal cord neurons]; depending on the treatment protocol and device settings it may be used for opioid withdrawal symptoms (e.g., bone/joint aches, tremor, anxiety), or irritable bowel syndrome [IBS]-associated functional abdominal pain (FAP). It consists of an electrical pulse generator with minimally-invasive electrodes, and accessories (e.g., adhesives, transilluminator). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
812-689-0791tom@i-h-s.com
812-689-0791tcarrico@neuraxis.com

Regulatory Flags#

DUNS number
063076701
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B960NSS2031NSS IB-STIMIB-STIM01-10202020-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08908006064311Morph DeviceNEUROSTIMULATION MEDTECH PRIVATE LIMITEDPZR2026-05-22
08908006064083Drug Relief v1NEUROSTIMULATION MEDTECH PRIVATE LIMITEDPZR2026-03-16
08908006064205OpiEaseNEUROSTIMULATION MEDTECH PRIVATE LIMITEDPZR2026-03-16
00850052017552Sparrow AscentSpark Biomedical Inc.PZR2026-02-02
08908006064113Morph DeviceNEUROSTIMULATION MEDTECH PRIVATE LIMITEDPZR2024-07-20
08908006064120S.T. GenesisNEUROSTIMULATION MEDTECH PRIVATE LIMITEDPZR2024-07-20
08908006064106OpiReliefNEUROSTIMULATION MEDTECH PRIVATE LIMITEDPZR2024-07-19
00850052017019Sparrow Ascent Earpiece, RightSpark Biomedical Inc.PZR2023-09-07
00850052017033Sparrow Ascent Replacement KitSpark Biomedical Inc.PZR2023-09-07
00850052017040Sparrow Ascent CableSpark Biomedical Inc.PZR2023-09-07
00850052017071Sparrow Ascent 28 Piece Kit (B2B)Spark Biomedical Inc.PZR2023-09-07
00850052017088Sparrow Ascent 28 Piece Kit (B2C)Spark Biomedical Inc.PZR2023-09-07
00860005396948Sparrow Ascent Kit (B2C)Spark Biomedical Inc.PZR2023-09-07
00860005396955Sparrow Ascent Patient ControllerSpark Biomedical Inc.PZR2023-09-07
00860005396962Sparrow Ascent Earpiece, LeftSpark Biomedical Inc.PZR2023-09-07
00860005396979Sparrow Ascent CableSpark Biomedical Inc.PZR2023-09-07
00860005396986Sparrow Ascent Kit (B2B)Spark Biomedical Inc.PZR2023-09-07
B960NSS200NSS-2 BridgeNeuraxis, Inc.PZR2021-02-12
B327NSS200NSS-2KEY ELECTRONICS, INC.PZR2018-03-30