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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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Legend Pro VO hand piece is designed to deliver radiofrequency energy to the skin in a non-homogeneous fractional manner, via an array of multi-electrode pins. The array delivers bipolar RF energy to the skin, resulting in heating of skin directly below the electrodes, to temperatures leading to ablation and resurfacing of the skin.
POLLOGEN LTD
Legend Pro
In Commercial Distribution

  • 07290016586176 ()
20900330U

  • Radio-frequency skin surface treatment system
IV Stand for the Intelli-C X-ray system to be fixed in any position along the patient table to attach infusion bags during the examination.
Nrt - Nordisk Røntgen Teknik A/S
03285600
In Commercial Distribution

  • 05713464000435 ()


  • Freestanding/bed-attached intravenous pole
Cadence Tibial Impactor Tip is attached to the tibial impactor handle and is used to seat the Tibial Tray Implant on the distal tibia.
Ascension Orthopedics, Inc.
10203100
Not in Commercial Distribution

  • M268102031001 ()
  • 10381780240280 ()


  • Orthopaedic implant/instrument assembling device
Cadence Tibial Impactor Tip is attached to the tibial impactor handle and is used to seat the Tibial Tray Implant on the distal tibia.
Ascension Orthopedics, Inc.
10203101
In Commercial Distribution

  • 10381780356295 ()
10203101

  • Joint prosthesis implantation kit, reusable
A combination of single-use products intended to attach the Sentec sensors to the earlobe of the patient, recommended for patients with mature/intact skin.
SenTec AG
PAK-EC
Not in Commercial Distribution

  • 07640121880957 ()
  • 17640121880954 ()


  • Transcutaneous blood gas monitoring system
  • Transcutaneous blood gas monitor sensor
  • Pulse Co-oximeter probe, reusable
The reamer of diameter 10 mm and of total length 300 mm is used to ream the intramedullary canal to prepare the nail insertion.
NEWDEAL
519010ND
In Commercial Distribution

  • M248519010ND1 ()
  • 10381780045045 ()

  • 10.0mm diam. x 40mm reaming part length


  • Bone-resection orthopaedic reamer, single-use
Maintenance of the premolar and molar sectors, left-oriented Recommended for the maintenance of moderate to deep pockets and furcations. Equivalent to the Nabers probe
SATELEC
TIP TK2-1L
In Commercial Distribution

  • 03609820021621 ()
F02162

  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Alleye® is a vision function test provided on a commercially available mobile phone. Alleye® implements an alignment hyperacuity task which helps patients with age-related macular degeneration (AMD) to assess their vision at home. This allows the timely detection of significant changes in vision function, enabling the regular monitoring of the disease progression and/or verifying the efficacy of ongoing treatments. Alleye is a digital technology, consisting of two different items: a mobile app for patients and a web interface for eye care professionals. Principle of Operation The test consists of 12 tasks that are performed on the user’s mobile phone. For each task, two dots are placed at each extremity of an invisible axis. A third dot is placed between these two dots, 40 pixels above or 40 pixels below the axis. The test consists in aligning the three dots by moving the dot in the middle. A single click on the up and down buttons moves the dot by 0.3 pixels up or down, respectively. If the patient maintains their finger on the buttons, the dot keeps moving. When it reaches a limit of 50 pixels away from its ideal position on the axis, the dot automatically stops. Once the user is satisfied with the position of the middle dot, they confirm it by tapping the circle button between the two arrow buttons. Overall, the patient must perform three alignments on four different axes (horizontal, vertical, oblique upper left / lower right, and oblique upper right / lower left). The test is performed on one eye only. The eye that is not being tested must be covered before starting the test. The TRAINING mode allows the patient to learn how to use the app, without recording the score results. To start the test, the patient must select TEST, and then select the eye (RIGHT or LEFT) to be tested. The Alleye tasks will proceed until COMMENT ON TEST appears on the screen. The patient can select REPEAT to start the test again, or DONE to save the test and display the results.
OCULOCARE medical AG
3.2.12
In Commercial Distribution

  • EOMA32120 ()


  • Vision self-testing software
The projection perimeters is used to check the sensitivity of the human eye to light(visual acuity). Ambient light by refraction system to the retina, the retinal photochemical reactions by bioelectrical, transmitted through the visual pathway visual cortex, the brain through a comprehensive analysis of the formation of vision. Any part of the distribution from the retina to the visual cortex nerve fibers, direction, known as the road lesions occur, it will be reflected in the vision, visual field changes according to the results of other tests and clinical, can analyze the site of the lesion, nature and prognosis
Chongqing Kanghuaruiming S&T Co., Ltd..
APS-T00
In Commercial Distribution

  • 06951214400275 ()


  • Perimeter, automatic
The projection perimeters is used to check the sensitivity of the human eye to light(visual acuity). Ambient light by refraction system to the retina, the retinal photochemical reactions by bioelectrical, transmitted through the visual pathway visual cortex, the brain through a comprehensive analysis of the formation of vision. Any part of the distribution from the retina to the visual cortex nerve fibers, direction, known as the road lesions occur, it will be reflected in the vision, visual field changes according to the results of other tests and clinical, can analyze the site of the lesion, nature and prognosis.
Chongqing Kanghuaruiming S&T Co., Ltd..
APS-T90
In Commercial Distribution

  • 06951214400268 ()


  • Perimeter, automatic
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