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The IB-STIM (DEN180057) is a percutaneous electrical nerve field stimulator (PENFS) system, which is used in a target population of patients 11-18 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The IB-STIM is a battery-operated micro-stimulation appliance designed as a disposable product for a single use. The IB-STIM is placed behind the patient’s ear and connected to stimulation needles on the auricle. The IB-STIM offers regular therapy over several days and is intended to be used for 120 hours per week up to 3 consecutive weeks. The appliance transmits low-frequency electric pulses to exposed nerve endings.
Neuraxis, Inc.
IB-STIM
01-1020
- Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
The NSS Neurostim ((510K-140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of acute and/or chronic pain. The NSS Neurostim is a battery-operated micro-stimulation appliance designed as a disposable product for a single use. The NSS Neurostim is placed behind the patient’s ear and connected to stimulation needles on the auricle. The NSS Neurostim offers regular therapy over several days. The appliance transmits low frequency electric pulses to exposed nerve endings.
Neuraxis, Inc.
NeuroStim
01-1021
- Acupuncture electrical stimulation system
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.
Neuraxis, Inc.
Bridge
01-1017-NSS-2/BRIDGE
- Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
ProVeil™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. ProVeil™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries.
Checkpoint Surgical, Inc.
PV4030
In Commercial Distribution
- B130PV40301 ()
- B130PV40300 ()
- B130PV40302 ()
- B130PV40303 ()
PV4030
- Nerve guide, animal-derived
NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries.
Checkpoint Surgical, Inc.
NS4030
In Commercial Distribution
- B130NS40300 ()
- B130NS40301 ()
- B130NS40302 ()
- B130NS40303 ()
NS4030
- Nerve guide, animal-derived
NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries.
Checkpoint Surgical, Inc.
NS3020
In Commercial Distribution
- B130NS30201 ()
- B130NS30200 ()
- B130NS30202 ()
- B130NS30203 ()
NS3020
- Nerve guide, animal-derived
The Guardian Intraoperative Lead is a single-use, sterile medical device accessory consisting of an electrode for contacting nerve, a lead wire and a connector. The connector securely connects to a Checkpoint intraoperative stimulator to provide electrical stimulation of exposed motor nerves or muscle tissue. The Medium size has lead body width of approximately 7mm.
Checkpoint Surgical, Inc.
9525
In Commercial Distribution
- B13095251 ()
- B13095250 ()
- B13095252 ()
- B13095253 ()
- Width: 7 Millimeter
9525
- Nerve-locating system
The Guardian Intraoperative Lead is a single-use, sterile medical device accessory consisting of an electrode for contacting nerve, a lead wire and a connector. The connector securely connects to a Checkpoint intraoperative stimulator to provide electrical stimulation of exposed motor nerves or muscle tissue. The Small size has lead body width of approximately 4mm.
Checkpoint Surgical, Inc.
9524
In Commercial Distribution
- B13095241 ()
- B13095240 ()
- B13095242 ()
- B13095243 ()
- Width: 4 Millimeter
9524
- Nerve-locating system
Probe Extension, 4 cm for use with Checkpoint Stimulators`
Checkpoint Surgical, Inc.
9506
In Commercial Distribution
- B13095061 ()
- B13095060 ()
- B13095062 ()
- B13095063 ()
9506
- Nerve-locating system
Probe Extension with Ball Tip, 12 cm for use with Checkpoint Stimulators
Checkpoint Surgical, Inc.
9505
In Commercial Distribution
- B13095051 ()
- B13095050 ()
- B13095052 ()
- B13095053 ()
9505
- Nerve-locating system