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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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Clarius Ultrasound Scanner - 07540205000403

No Description
Clarius Mobile Health Corp
App - Android
In Commercial Distribution

  • 07540205000403 ()
12-01-00004

  • Ultrasound imaging system application software
  • Radiological PACS software

Clarius Ultrasound Scanner - 07540205000397

No Description
Clarius Mobile Health Corp
App - iOS
In Commercial Distribution

  • 07540205000397 ()
12-01-00003

  • Ultrasound imaging system application software
  • Radiological PACS software

Visix - 00851800007054

Visix 8.1 software Build 81
TELEVERE SYSTEMS, LLC
8.1 Build 81
In Commercial Distribution

  • 00851800007054 ()
Visix 8.1 Build 81

  • Radiological PACS software
  • General-purpose dental x-ray system application software
  • Camera application software
  • Basic diagnostic x-ray system application software

Visix - 00851800007047

Visix Pro software version 7.7.15
TELEVERE SYSTEMS, LLC
7.7.15
In Commercial Distribution

  • 00851800007047 ()
Visix Pro 7.7.15

  • Basic diagnostic x-ray system application software
  • Camera application software
  • General-purpose dental x-ray system application software
  • Radiological PACS software

Visix - 00851800007030

Visix software version 2.3.9
TELEVERE SYSTEMS, LLC
2.3.9
In Commercial Distribution

  • 00851800007030 ()
Visix 2.3.9

  • Radiological PACS software
  • General-purpose dental x-ray system application software
  • Camera application software
  • Basic diagnostic x-ray system application software

Skytron Mounting rails - 10841736114091

GCX Mounting rails for front supports in PM/KM/XM carriers only (set, includes hardware) H8-010-51 GCX track sold separately
SKYTRON LLC
H8-200-01-GCX
In Commercial Distribution

  • 10841736114091 ()


  • General utility supply system, ceiling-mounted

External Fixator Pin cluster clamp 15 Stainless steel hardware - 07640136270019

Element intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.
GEXFIX SA
1010-1010
In Commercial Distribution

  • 07640136270019 ()


  • External orthopaedic fixation system, single-use

Pathway® - 00852423006394

Pathway® NMR 200 Dual Channel Module
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
NMR 200
In Commercial Distribution

  • 00852423006394 ()
NMR 200

  • Perineometer
  • Psychophysiological biofeedback system

Pathway - 00852423006073

Pathway® MR-10 Single Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-10
In Commercial Distribution

  • 00852423006073 ()
9700

  • Perineometer
  • Psychophysiological biofeedback system

Pathway - 00852423006066

Pathway® MR-15 Single Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-15
In Commercial Distribution

  • 00852423006066 ()
9715

  • Perineometer
  • Psychophysiological biofeedback system
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