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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 Size Type Device Class Implantable

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Sonasource is comprised of several integrated programmable hardware and software modules that are used to drive and control SonaCare Medical's probes. The console includes all electronics required for user interaction with all probe imaging and treatment functions.
FOCUS SURGERY INC
102-17000-0009
In Commercial Distribution

  • 00868108000212 ()


  • Ultrasonic hyperthermia system
54 Unit Mining First Aid Kit - Contains: Adhesive Plastic Bandages, 1" x 3", 16 ct; Aluminized Rescue Blanket, 52" x 84"; Ammonia Inhalants, 20 ct; First Aid Guide; First Aid/Burn Cream Packets, 12 ct; Hema-Flex Bandage Compress, 2", 8 ct; Hema-Flex Bandage Compress, 4", 8 ct; Padded Flexible Splint, 4" x 24"; Stretch Tourniquet, 1" x 18", 2 ct; Triangular Bandage, 40" x 40" x 56", 24 ct; Triple Antibiotic Ointment Packets, 12 ct.
Acme United Corporation
90795
In Commercial Distribution

  • 00092265907958 ()
90795

  • First aid kit, medicated
Desk to Full Armrest Extension Kit. Armrest Extension tube (insert) to allow longer tube lengths for mounting full length arm pads or to allow for greater arm pad depth adjustment. Mounting hardware included. Kit contains one extension tube
Motion Concepts Inc
D-0123-0128-AEXT
In Commercial Distribution

  • 07540147002893 ()
AEXT

  • Wheelchair armrest
Heavy-Duty 70° Swing Away Legrest Set. Set includes 2 upper down tube assemblies and 2 extension tube assemblies. Hardware included. Three extension tube options/sizes available: 11"-15", 13"-17", 16"-20". Footplates and footplate mounts sold separately.
Motion Concepts Inc
D-0130-HD70
In Commercial Distribution

  • 07540147002855 ()
HD70S

  • Wheelchair footrest/legrest
The MediPines Gas Exchange Monitor (GEM) is a non-invasive, multi-parameter respiratory monitoring device that provides spot-check respiratory gas measurements of oxygen (PO2, ETO2) and carbon dioxide (PCO2, ETCO2) from breathing, respiration rate (RR), functional saturation of arterial hemoglobin (SpO2), pulse rate (PR), and a range of other calculated indices.
MEDIPINES CORPORATION
AGM100
In Commercial Distribution

  • 00860001261509 ()
AGM100

  • Multiple vital physiological parameter monitoring system, clinical
  • Respiration monitor
  • Patient monitoring system module, multiple-gas
The SpineUs™ System is a diagnostic ultrasound system, which consists of the FDA cleared Clarius Ultrasound Scanner C3 HD3 (K213436), a consumer PC, a tracking system with OptiTrack cameras connected to a POE switch and active LED markers, and the SpineUs™ computer application. The SpineUs™ computer application, installed in the consumer PC, processes the ultrasound imaging data received from the Clarius Ultrasound Scanner and the tracking data received from the tracking system. The SpineUs™ computer application allows the operator to view ultrasound images of the spine, segment the ultrasound images using artificial intelligence, generate and visualize 3D reconstructions of the surface of the spine in real-time, measure spine-related anatomical components (e.g., intervertebral angles and spine curvature), review and manage patient measurement data, and generate and export printable reports.
VERDURE IMAGING, INC.
000010
In Commercial Distribution

  • G618000010 ()


  • Ultrasound imaging system operation software
  • Hand-held ultrasound imaging system, body-surface
  • Ultrasound imaging system operator console
No Description
Thought Technology Ltd.
SA9020
In Commercial Distribution

  • 07540191000593 ()


  • Psychophysiological biofeedback system
  • Physical therapy transcutaneous neuromuscular electrical stimulation system
  • Perineal orifice incontinence-control electrical stimulation system probe, reusable
No Description
Thought Technology Ltd.
SA9030
In Commercial Distribution

  • 07540191000586 ()


  • Psychophysiological biofeedback system
  • Physical therapy transcutaneous neuromuscular electrical stimulation system
  • Perineal orifice incontinence-control electrical stimulation system probe, reusable
Quad-Link Swing-Away Joystick Mount Assembly. Components/hardware used to mount the Quad-Link Swing-Away Joystick assembly onto the armrest on a Motion Concepts Power Positioning System. Straight or jogged tube option available. Can be mounted onto Left or Right armrests.
Motion Concepts Inc
D-0181-SAQ
In Commercial Distribution

  • 07540147001995 ()
SAQ

  • Wheelchair bracket/mount
V3D-Calcium Scoring is a software application used with advanced PC hardware for coronary artery calcification scoring. It is designed to utilize DICOM 3.0 compliant medical images derived from gated CT heart scan without the use of any contrast agent.
VIATRONIX INCORPORATED
2.1
In Commercial Distribution

  • B209CAS2X10 ()


  • Radiological PACS software
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