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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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TigerView Pro software version 7.7.3
TELEVERE SYSTEMS, LLC
7.7.3
In Commercial Distribution

  • 00851800007023 ()
TigerView Pro 7.7.3

  • Radiological PACS software
  • General-purpose dental x-ray system application software
  • Multidisciplinary medical image management software
  • Camera application software
  • Basic diagnostic x-ray system application software
TigerView 8.1 software Build 81
TELEVERE SYSTEMS, LLC
8.1 Build 81
In Commercial Distribution

  • 00851800007016 ()
TigerView 8.1 Build 81

  • Basic diagnostic x-ray system application software
  • Camera application software
  • Multidisciplinary medical image management software
  • General-purpose dental x-ray system application software
  • Radiological PACS software
TigerView Pro software version 7.7.13
TELEVERE SYSTEMS, LLC
7.7.13
In Commercial Distribution

  • 00851800007009 ()
TigerView Pro 7.7.13

  • Radiological PACS software
  • General-purpose dental x-ray system application software
  • Multidisciplinary medical image management software
  • Camera application software
  • Basic diagnostic x-ray system application software
The EXOGEN device provides non-invasive therapy for healing non-unions and accelerating time to healing of fresh fractures. The EXOGEN Ultrasound Bone Healing Systems has been designed both for use with conservatively treated fresh fractures and non-unions or surgically treated non-unions. The device transmits a low intensity ultrasound signal to the fracture site through coupling gel, with little or no sensation felt by the patient during the treatment. The low-intensity pulsed ultrasound has been shown in in-vitro and in-vivo studies to stimulate cells to produce growth factors and proteins that are important to bone healing. The patient administers treatment at home or at work, once daily, for 20 minutes, or as prescribed by a physician. The device automatically alerts the patient in case of improper application or device performance. The EXOGEN Ultrasound Bone Healing System consists of one main operating unit, gel bottles and strap. The main operating unit provides the treatment control circuitry, the primary battery supply, and monitors the operation of the transducer at the fracture site. The signal specifications cannot be changed.
BIOVENTUS LLC
71034600
In Commercial Distribution

  • M937710346001 ()
71034600

  • Bone growth ultrasonic stimulator
  • Radiographic image marker, manual
  • Skin topical coupling gel
  • Personal device holder, single-use
Cheeck Retractor for photo acquisition. ScanBox pro M-L Pack -The kit contains 4 elements: 2 Cheek Retractors: one Medium size (M) and one Large size (L). 1 Adapter 1 Phone support.
DENTAL MONITORING
001
In Commercial Distribution

  • 03770021392848 ()
  • 03770021392800 ()
  • 03770021392022 ()
1010-001

  • Dental cheek retractor, professional, reusable
  • Dental cheek retractor, home-use
Cheeck Retractor for photo acquisition. ScanBox pro S-M Pack -The kit contains 4 elements: 2 Cheek Retractors: one Small size (S) and one Medium size (M). 1 Adapter 1 Phone support.
DENTAL MONITORING
001
In Commercial Distribution

  • 03770021392831 ()
  • 03770021392794 ()
  • 03770021392015 ()
1009-001

  • Dental cheek retractor, professional, reusable
  • Dental cheek retractor, home-use
PC-ECG Acquisition Device for Resting-ECG and Stress-Test ECG applications with AHA labelling. The very high signal resolution allows the device to be used for scientific diagnostics (e.g. Late Potential or HRV).
NORAV MEDICAL LTD.
PCECG 1200HR
In Commercial Distribution

  • 07290110252892 ()
  • 07290110252878 ()
1200HR-D-00U-01

  • Electrocardiographic signal amplifier
Pediatric Intermittent Catheter, Coude-tip with hydrophilic coating
MEDICAL TECHNOLOGIES OF GEORGIA, INC.
81610
In Commercial Distribution

  • 20851593006313 ()
  • 10851593006316 ()
  • 00851593006319 ()

  • Catheter Gauge: 10 French


  • Single-administration urethral catheterization kit, single-use
Truer Medical Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials
TRUER MEDICAL, INC.
90116
In Commercial Distribution

  • 10859290006431 ()
  • 00859290006434 ()
90116

  • Gas-sampling/monitoring respiratory tubing, single-use
The BPro® BT Ambulatory Blood Pressure Monitoring system is a noninvasive ambulatoryblood pressure monitoring system based on arterial tonometry at the radial artery of the wrist with radial pulse waveform acquisition.
HEALTHSTATS INTERNATIONAL PTE LTD
T6200 series
In Commercial Distribution

  • 08885014410098 ()


  • Blood pressure ambulatory recorder
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