Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Class Implantable

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Morph Device
DYANSYS INDIA PRIVATE LIMITED
Morph Device
In Commercial Distribution

  • 08908006064113 ()


  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
OpiRelief
DYANSYS INDIA PRIVATE LIMITED
OpiRelief
In Commercial Distribution

  • 08908006064106 ()


  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
The Sparrow Ascent is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasive, transcutaneous stimulation of the nerves on and/or around the auricle (ear). The device is indicated as an aid in the reduction of opioid withdrawal symptoms in adult patients. The Sparrow Ascent is a battery operated, prescription device that delivers mild electrical stimulation to the nerves on and/or around the auricle (ear), which carry information to the central nervous system. The Sparrow Ascent is to be used in clinical environments (e.g., doctor’s office, clinics, rehab centers, and hospitals) and/or at home. Users of the subject device include adults experiencing opioid withdrawal symptoms. Stimulation parameters (i.e., the strength of stimulation) are set by the user’s clinician, and users can only adjust stimulation intensity at home. The system consists of three main components 1) a disposable Earpiece, 2) a Cable, and 3) the External Pulse Generator (EPG).
Spark Biomedical Inc.
11-320-K
In Commercial Distribution

  • 00860005396986 ()


  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
The Sparrow Ascent Cable is 37 inches long and connects the Patient Controller to the Earpiece. The Cable length is designed to allow the user to carry the Patient Controller in a pocket or worn in the Belt Clip(model 610) without constricting mobility. A built-in retention clip allows the user to clip the Cable to their clothing to relieve cable strain. This is a subcomponent and is not transacted. See 810-P.
Spark Biomedical Inc.
810
In Commercial Distribution

  • 00860005396979 ()


  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
The Earpiece is a disposable component of the Sparrow Ascent and is designed to stay adhered to the skin of the left or right ear for up to 24 hours of electrical connectivity. The Inner Electrode interfaces with the cymba concha and the Outer Electrode interfaces with the trigeminal nerve. The Back Electrode is the return Electrode for both the Inner and Outer Electrodes.
Spark Biomedical Inc.
210
In Commercial Distribution

  • 00860005396962 ()
  • 00860005396993 ()
  • 00850052017064 ()


  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
The Sparrow Ascent Patient Controller is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasive, transcutaneous stimulation of the nerves on and/or around the auricle (ear). The device is indicated as an aid in the reduction of opioid withdrawal symptoms in adult patients. The Patient Controller is a battery operated, prescription device that delivers mild electrical stimulation to the nerves on and/or around the auricle (ear), which carry information to the central nervous system. This is a subcomponent and is not transacted. See 11-110-K.
Spark Biomedical Inc.
110
In Commercial Distribution

  • 00860005396955 ()


  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
The Sparrow Ascent is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasive, transcutaneous stimulation of the nerves on and/or around the auricle (ear). The device is indicated as an aid in the reduction of opioid withdrawal symptoms in adult patients. The Sparrow Ascent is a battery operated, prescription device that delivers mild electrical stimulation to the nerves on and/or around the auricle (ear), which carry information to the central nervous system. The Sparrow Ascent is to be used in clinical environments (e.g., doctor’s office, clinics, rehab centers, and hospitals) and/or at home. Users of the subject device include adults experiencing opioid withdrawal symptoms. Stimulation parameters (i.e., the strength of stimulation) are set by the user’s clinician, and users can only adjust stimulation intensity at home. The system consists of three main components 1) a disposable Earpiece, 2) a Cable, and 3) the External Pulse Generator (EPG).
Spark Biomedical Inc.
11-310-K
In Commercial Distribution

  • 00860005396948 ()


  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
A starter pack with all the components for acute withdrawal management using Transcutaneous Auricular Neurostimulation (tAN®). This pack includes the Sparrow Ascent Kit and three Sparrow Ascent Left Earpiece Kits. (1) GTIN: 00860005396986 (Base kit containing the Patient Controller, Cable, Belt Clip, QSG, Batteries, seven Alcohol Wipes, and seven Left Earpieces) (3) GTIN: 00860005396993
Spark Biomedical Inc.
11-310-K-28
In Commercial Distribution

  • 00850052017088 ()


  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
A starter pack with all the components for acute withdrawal management using Transcutaneous Auricular Neurostimulation (tAN®). This pack includes the Sparrow Ascent Kit and three Sparrow Ascent Left Earpiece Kits. (1) GTIN: 00860005396986 (Base kit containing the Patient Controller, Cable, Belt Clip, QSG, Batteries, seven Alcohol Wipes, and seven Left Earpieces) (3) GTIN: 00860005396993
Spark Biomedical Inc.
11-320-K-28
In Commercial Distribution

  • 00850052017071 ()


  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
The Sparrow Ascent Cable is 37 inches long and connects the Patient Controller to the Earpiece. The Cable length is designed to allow the user to carry the Patient Controller in a pocket or worn in the Belt Clip(model 610) without constricting mobility. A built-in retention clip allows the user to clip the Cable to their clothing to relieve cable strain.
Spark Biomedical Inc.
810-P
In Commercial Distribution

  • 00850052017040 ()


  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
Separate item for replacement. The Sparrow Ascent Patient Controller is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasive, transcutaneous stimulation of the nerves on and/or around the auricle (ear). The device is indicated as an aid in the reduction of opioid withdrawal symptoms in adult patients. The Patient Controller is a battery operated, prescription device that delivers mild electrical stimulation to the nerves on and/or around the auricle (ear), which carry information to the central nervous system.
Spark Biomedical Inc.
11-110-K
In Commercial Distribution

  • 00850052017033 ()


  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
The Earpiece is a disposable component of the Sparrow Ascent and is designed to stay adhered to the skin of the left or right ear for up to 24 hours of electrical connectivity. The Inner Electrode interfaces with the cymba concha and the Outer Electrode interfaces with the trigeminal nerve. The Back Electrode is the return Electrode for both the Inner and Outer Electrodes.
Spark Biomedical Inc.
211
In Commercial Distribution

  • 00850052017019 ()
  • 00850052017002 ()
  • 00850052017057 ()


  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
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 weighing approximately 5 grams 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.
KEY ELECTRONICS, INC.
IB-STIM
In Commercial Distribution

  • B327NSS2032 ()
  • B327NSS203 ()
  • B327NSS2031 ()
01-1020

  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
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.
Bridge
In Commercial Distribution

  • B327NSS200 ()
  • B327NSS2002 ()
  • B327NSS2001 ()
01-1017-NSS-2/Bridge

  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
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
In Commercial Distribution

  • B960NSS2001 ()
  • B960NSS200 ()
  • B960NSS2002 ()
  • B327NSS200 ()
  • B960NSS2003 ()
01-1017-NSS-2/BRIDGE

  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
Knot pusher for placing knots for laparoscopic surgery. The various Knotpushers are intended for ligature passing and knot tying.
AMI Agency for Medical Innovations GmbH
APK 001
Not in Commercial Distribution

  • EAMIAPK0010 ()
APK 001

  • Suture knot pusher, reusable
Compatible with GE, 3 Lead Grouped ECG lead wires,Pinch,AHA
APK Technology Co.,Ltd.
A3157-EL1-001
In Commercial Distribution

  • 06946725538869 ()


  • Electrocardiographic lead set, reusable
GE Apex Pro FH-Philips 5L ECG Adapter
APK Technology Co.,Ltd.
A-CO-190
In Commercial Distribution

  • 16946725590789 ()
  • 06946725529942 ()
  • 16946725590956 ()


  • Electrocardiographic lead set, reusable
Temperature Adaptter Cable
APK Technology Co.,Ltd.
DHP-30-AD0
Not in Commercial Distribution

  • 06946725529072 ()


  • Electrocardiographic lead set, reusable
Mindray Bene/Pass-Philips 5L ECG Adapter
APK Technology Co.,Ltd.
A-CO-183
In Commercial Distribution

  • 06946725529041 ()
  • 16946725590642 ()
  • 16946725590925 ()


  • Electrocardiographic lead set, reusable
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