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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
FirstPlug Screw Channel Barrier 210cm
35newtons L.L.C.
P000017-005
In Commercial Distribution
- 00860005367252 ()
P000017-005
- Antimicrobial dental prosthesis/implant plug
FirstPlug Screw Channel Barrier 210 cm
35newtons L.L.C.
P000017-004
In Commercial Distribution
- 00860005367238 ()
P000017-004
- Antimicrobial dental prosthesis/implant plug
FirstPlug Screw Channel Barrier 210 cm
35newtons L.L.C.
P000017-003
In Commercial Distribution
- 00860005367221 ()
P000017-003
- Antimicrobial dental prosthesis/implant plug
FirstPlug Screw Channel Barrier 210 cm
35newtons L.L.C.
P000017-001
In Commercial Distribution
- 00860005367207 ()
P000017-001
- Antimicrobial dental prosthesis/implant plug
The Spatz3 Adjustable Balloon System is indicated for temporary use for weight loss in adults with obesity Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with one or more major obesity-related comorbid conditions who have failed to achieve and maintain weight-loss with a supervised weight control program. The Spatz3 Adjustable Balloon System is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of long-term weight-loss maintenance. The maximum placement period for Spatz3 Adjustable Balloon System is 8 months.
SPATZ FGIA (ISRAEL) LTD
A-SP3US-03K
In Commercial Distribution
- 00860005178803 ()
- Appetite-suppression gastric balloon
Qure.ai Head CT scan interpretation software, qER, is a deep-learning-based software device that analyses head CT scans for signs of intracranial hemorrhage, midline shift, mass effect or cranial fractures in order to prioritize them for clinical review. The standalone software device consists of an on-premise module and a cloud module. qER accepts non-contrast adult head CT scan DICOM files as input and provides a priority flag indicating critical scans.
QURE.AI TECHNOLOGIES PRIVATE LIMITED
2.0.0
In Commercial Distribution
- 00860005118106 ()
- Radiology DICOM image processing application software
No Description
WAHTS HEARING LLC
0.X.X
In Commercial Distribution
- 00860005068319 ()
- Tone audiometer