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No Description
Azure Biosystems Inc.
Azure Cielo 3 Dx
In Commercial Distribution
- 00860006465605 ()
- Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
No Description
Tmr Orthopedics, LLC
TMR 001-6.5-120
In Commercial Distribution
- 00860006173302 ()
- Orthopaedic bone screw, non-bioabsorbable, non-sterile
ParallelTM is a Prescription Digital Therapeutic (PDT) web application designed to deliver Cognitive Behavioral Therapy (CBT) to patients with Irritable Bowel Syndrome (IBS).
Mahana Therapeutics, Inc.
01-0001-001
In Commercial Distribution
- 00860006172008 ()
01-0001-001
- Mindfulness/behavioural therapy software, non-clinician-consultative
Regulora® is prescription-only digital therapeutic (PDT) software indicated for use in the treatment of abdominal pain due to Irritable Bowel Syndrome (IBS). The Regulora program is Software as a Medical Device (SaMD) that resides on and is accessed through the user’s mobile device and can be executed at home. Regulora digitizes scripted therapist-administered gut-directed psychotherapy and provides 7 unique treatment sessions, each lasting ~30 minutes, every other week over 12 weeks. The treatment sessions are designed to first induce deep physical and autonomic relaxation which is followed by metaphorical storytelling and a combination of direct and indirect suggestions targeted at somatic control mechanisms. Regulora also provides for IBS symptom tracking, which patients can share with their doctor in the management of their IBS.
Metame Health, Inc.
GDH-1
In Commercial Distribution
- 00860005970209 ()
60005-97020
- Mindfulness/behavioural therapy software, non-clinician-consultative
The MIS Precision Chevron Bunion System™ is a kit designed to allow surgeons to perform a chevron bunion osteotomy, and subsequent fixation of the osteotomy, with a minimally invasive surgical technique. The MIS Precision Chevron Bunion System™ consists of a single, sterile-packaged SKU that contains both implants and instruments needed for the procedure.
The implants in the kit are cannulated headless compression screws, made from titanium (Ti-6AL-4V ELI). There are two implants in the kit, however only one is used in a surgical procedure. Two implants are provided to allow the physician to select the proper size for the patient at the time of surgery. The implants are 3.5 mm diameter, with lengths of 24 mm and 27 mm.
There are also single-use instruments, made of injection molded polycarbonate, PEEK, and stainless steel included in the MIS Precision Chevron Bunion System™. Instruments include an osteotomy guide (one each for left and right feet), a targeting guide, a screw guide, screwdriver, drill bit, and several K-wires and a guidewire.
Additional general surgical instrumentation is utilized, but not part of the RELJA system, such as sagittal saw, drivers, and scalpel.
Relja Innovations LLC
RI-2427-C
In Commercial Distribution
- 00860005968800 ()
- Orthopaedic bone screw, non-bioabsorbable, sterile
Box of 24 masks; Note: individual masks are NOT for sale.
Intended use:
The ClearMask Transparent Surgical Face Mask is intended for use in healthcare settings, such as in operating rooms, or in other medical procedures such as dental, isolation and veterinary procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device allows for full view of the face and facial expressions, particularly the nose and mouth areas.
The device is indicated for over-the-counter use. The device is disposable and is indicated for single use. The device is not provided sterile.
Clearmask, LLC
v1.0
In Commercial Distribution
- 10860005106025 ()
- 00860005106028 ()
- 20860005106022 ()
- 00860005106035 ()
- Surgical/medical face mask, single-use
ScarMD Silicone Scar Gel 6g Glide
AIM MEDICAL INC.
30mL Spray
In Commercial Distribution
- 00860004589747 ()
- Scar management dressing, single-use, sterile
Stainless Steel 20" seat width - transport chair, 12-1/2" rear wheels, 300lb. capacity, less front rigging, Green
Assembly Required Distributors Inc
WCM2025NF50
In Commercial Distribution
- 00860004575610 ()
- Bariatric transport wheelchair, collapsible
physIQ convenience kit including mobile relay device pre-loaded with physIQ monitoring software, biosensors, and skin preparation
PHYSIQ, INC
Model C
In Commercial Distribution
- 00860004366294 ()
- Electrocardiography telemetric monitoring system
physIQ convenience kit including mobile relay device pre-loaded with physIQ monitoring software, biosensors, and skin preparation.
PHYSIQ, INC
Model B
In Commercial Distribution
- 00860004366287 ()
- Electrocardiography telemetric monitoring system