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Nss-2

FDA UDI

Class II (US FDA UDI)

by Key Electronics, Inc.

Identity

Trade Name
NSS-2 FDA UDI
Generic Name
Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator FDA UDI
Device Name
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. FDA UDI
Model / Reference
Bridge FDA UDI
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. FDA UDI

Identifiers

Catalog Number
01-1017-NSS-2/Bridge FDA UDI
Primary DI / UDI-DI
B327NSS200 FDA UDI
510(k) Number
DEN170018 FDA UDI
FDA Product Code
PZR FDA UDI
GMDN Term
Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5896 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator

Nss-2 by Key Electronics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Key Electronics, Inc.

Sources (1)

  • FDA UDI 2d6d952d-c85d-4dad-803e-512cd1765e3e 35 fields · synced Jun 8, 2026