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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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PanoCam™ PRO Ophthalmic Digital Imaging System is developed using the state-of-the art and proprietary technologies for imaging the fundus, cornea and exterior of the eyes. The system consists of the standard lens and the optional high magnification lens which capture True-color™ high-resolution images of the eyes regardless of the retinal pigment color and with a field of view of up to 130 degrees and approximately 80 degrees, respectively. PanoCam™ PRO is a fully integrated system consisting of the wireless IRIS™ (Independent Remote Imaging Station) and the Imaging System Console on a cart. It is highly mobile, as the cart can be easily move around within hospital facilities and the untethered and light weight IRIS™ hand piece allows convenient image capture in multiple locations away from the console. The software is DICOM compliant, allowing data and images to be transferred easily and securely using wireless connections. PanoCam™ PRO is user friendly and can be operated by a single individual with proper training. The system is ideally suited as a diagnostic and observation instrument for ophthalmologists in clinics and surgical rooms. It can be used for general ophthalmic imaging and eye disease inspection.
VISUNEX MEDICAL SYSTEMS INC.
PNPR-11-10-23
In Commercial Distribution

  • 00850938007028 ()


  • External ocular measurement camera
PanoCam™ PRO Ophthalmic Digital Imaging System is developed using the state-of-the art and proprietary technologies for imaging the fundus, cornea and exterior of the eyes. The system consists of the standard lens and the optional high magnification lens which capture True-color™ high-resolution images of the eyes regardless of the retinal pigment color and with a field of view of up to 130 degrees and approximately 80 degrees, respectively. PanoCam™ PRO is a fully integrated system consisting of the wireless IRIS™ (Independent Remote Imaging Station) and the Imaging System Console on a cart. It is highly mobile, as the cart can be easily move around within hospital facilities and the untethered and light weight IRIS™ hand piece allows convenient image capture in multiple locations away from the console. The software is DICOM compliant, allowing data and images to be transferred easily and securely using wireless connections. PanoCam™ PRO is user friendly and can be operated by a single individual with proper training. The system is ideally suited as a diagnostic and observation instrument for ophthalmologists in clinics and surgical rooms. It can be used for general ophthalmic imaging and eye disease inspection.
VISUNEX MEDICAL SYSTEMS INC.
PNPR-11-10-11
In Commercial Distribution

  • 00850938007011 ()


  • External ocular measurement camera
PanoCam™ LT Wide-field Digital Imaging System is developed using the state-of-the art and proprietary technologies for imaging the fundus, cornea and exterior of the eyes. It provides True-color™ high-resolution images of the eyes of the patients regardless of the retinal pigment color and with a field of view of up to 130 degrees. PanoCam™ LT is a fully integrated system consisting of the Image Capturing Unit™, Computer Console, and Integrated Color Printer. It is highly mobile, allowing convenient image capture by the untethered Image Capturing Unit™ hand piece in multiple hospital rooms and exam lanes. The software is DICOM compliant, allowing data and images to be transferred easily and securely using wireless connections. PanoCam™ LT is ideally suited as a mobile device for general ophthalmic imaging and eye disease inspection.
VISUNEX MEDICAL SYSTEMS INC.
PNLT-10-10-11
In Commercial Distribution

  • 00850938007004 ()


  • External ocular measurement camera
Features: 1.LCD screen 2.2 output ports 3.10-60 minutes adjustable 4.Rechargeable built-in lithium battery Functions: 1.Eliminate body fatigue 2.Relax muscles and joints 3.Improve blood circulation 4.Increase metabolism and prevent many work related symptoms Specifications 1.Power/voltage: 3.7V 2.Massage issuing frequency: 1~110Hz 3.Consumed current: 40mA 4.Status adjustment: 6 kinds of status
HOME AIDE DIAGNOSTICS, INC.
SM9128
In Commercial Distribution

  • 00850632007188 ()
  • 10850632007185 ()
7188

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
The PulStar Spine Mobilization Device is intended for use by chiropractors, physical therapists and physicians for mobilization of the spine. The device consists of a hand-held impulse head attached to an electronic control module. The control module is connected to an Apple computer through a USB cable. Appropriate software is used to display the results of tissue compliance measurements. Intended Use and operation: Intended use of the PulStar is for the treatment of musculoskeletal pain due to joint subluxation, restricted joint mobility, myofacial spasm and ligamentous strain. The clinician uses a hand held impulse head to test the stiffness of the patient’s spine at each vertebral level, the results of this procedure are recorded in the patient file in a computer database and displayed on the computer screen. The clinician then decides where therapy is needed and applies multiple impulses with the impulse head to those areas of the body of the patient with the intent of reducing spinal stiffness. After treatment, the clinician repeats the initial test of the patient’s spine to document changes in stiffness effected by the therapy.
Sense Technology, Inc.
G3
In Commercial Distribution

  • 10855341008003 ()
  • 00855341008006 ()


  • Joint/spinal manipulator, electronic
ConstaVac CBCIII Blood Conservation Kit with 4.8 mm Round PVC Wound Drain
3T MEDICAL SYSTEMS, INC.
225-426-000W
In Commercial Distribution

  • 00855168008654 ()
  • 00855168008661 ()

  • 4.8 Millimeter
225-426-000W

  • Whole-blood-recovery autotransfusion system, powered
ConstaVac CBCIII Conservation Kit with 3.2 mm Round PVC Wound Drain
3T MEDICAL SYSTEMS, INC.
225-414-000W
In Commercial Distribution

  • 00855168008630 ()
  • 00855168008647 ()

  • 3.2 Millimeters
225-414-000W

  • Whole-blood-recovery autotransfusion system, powered
CBCII Constavac Blood Conservation System (No Drain)
3T MEDICAL SYSTEMS, INC.
225-028-000E
In Commercial Distribution

  • 00855168008388 ()
  • 00855168008371 ()
225-028-000E

  • Whole-blood-recovery autotransfusion system, powered
CBCII 1/8" Double Trocar with Quick Disconnect
3T MEDICAL SYSTEMS, INC.
225-028-085S1
Not in Commercial Distribution

  • 00855168008340 ()
  • 00855168008333 ()

  • 3.2 Millimeter
225-028-085S1

  • Whole-blood-recovery autotransfusion system, powered
ConstaVac CBCII with Quick Disconnect, 3/16” Round PVC Drain & Trocar
3T MEDICAL SYSTEMS, INC.
225-028-926
In Commercial Distribution

  • 00855168008302 ()
  • 00855168008296 ()

  • 4.8 Millimeter
225-028-926

  • Whole-blood-recovery autotransfusion system, powered
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