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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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The Orpyx® Custom Sensory Insole renewal is a pair of custom sensory insoles with 4 months of remote patient monitoring support. The renewal insoles work as part of the Orpyx Sensory Insole system. The following is included: 1 pair of custom insoles - Instructions for use manual - 4 months of RPM support
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000356 ()
10185571000356

  • Pressure monitoring insole
The Orpyx® Custom Sensory Insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into custom fabricated shoe insoles which wirelessly communicates with a display application running on a smartphone or digital display. In addition to pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by the device and sent to the cloud for remote monitoring purposes. The following is included: 1 pair of custom insoles - Digital Display - Charging accessories - Instructions for use manual - 6 months of RPM support
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000349 ()
10185571000349

  • Pressure monitoring insole
The Orpyx® Custom Sensory Insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into custom fabricated shoe insoles which wirelessly communicates with a display application running on a smartphone or digital display. In addition to pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by the device and sent to the cloud for remote monitoring purposes. The following is included: 1 pair of custom insoles - Digital Display - Charging accessories - Instructions for use manual - 12 months of RPM support
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000332 ()
10185571000332

  • Pressure monitoring insole
The Orpyx® Flex Sensory insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into pre-fabricated shoe insoles which wirelessly communicates with a display application running on a smartphone or digital display. In addition to pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by the device and sent to the cloud to enable remote monitoring. The following is included in the Orpyx Flex Sensory Insoles Start Up Kit: - 1 pair of flex insoles - Digital Display - Charging accessories - Instructions for use manual
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000172 ()
10185571000172

  • Pressure monitoring insole
Adaptive classroom desk
RIFTON EQUIPMENT
R240
In Commercial Distribution

  • 00850001752473 ()


  • Ergonomic workdesk, manual
Adaptive classroom desk
RIFTON EQUIPMENT
R250
In Commercial Distribution

  • 00850001752428 ()


  • Ergonomic workdesk, manual
iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400063
In Commercial Distribution

  • J00714000630631 ()
1400063

  • Dental treatment application software
N/A
Carl Zeiss Vision GmbH
000000-2360-422
In Commercial Distribution

  • 04250668606632 ()
000000-2360-422

  • Corneal topography system application software
No Description
SOMNOmedics AG
ABP050U
In Commercial Distribution

  • 04250413405640 ()


  • Blood pressure ambulatory recorder
Intra Oral Camera, Direct-USB, Auto-Focus
Beyes Dental Canada Inc
EV2060
In Commercial Distribution

  • 00628504370056 ()


  • Intraoral camera
KOWA FM-600 is an instrument to measure the protein level contained in aqueous humor of the anterior chamber of human eye.
KOWA COMPANY,LTD.
LSS50BK
In Commercial Distribution

  • 04987646804024 ()

  • Height: 458 Millimeter
  • Depth: 457 Millimeter
  • Width: 274 Millimeter
  • Weight: 18 Kilogram


  • Aqueous flare/cell measuring system
No Description
COCHLEAR LIMITED
Osia 2 System
In Commercial Distribution

  • 09321502045124 ()
P1343785

  • Hearing implant system sound processor activation kit
No Description
PAR Medizintechnik GmbH & Co. Kommanditgesellschaft
2001589-202
In Commercial Distribution

  • 04260671371021 ()


  • Blood pressure ambulatory recorder
The R2*/T2* phantom is a medical device accessory intended to be used as an alternative to human test subject to avoid potential complications for an MRI centre in order to evaluate that the scanning protocol have been correctly set up for the analysis of cardiac R2* and T2* values using the CardiacT2* on 1.5T and 3T MRI scanners. The R2*/T2* Phantom consists of an amber bottle having 09 (nine) plastic tubes (30mL) of 0.8% Agarose (C24H38O19) gel doped with varying known concentrations (0.10 mM to 3.2 mM) of manganese chloride (MnCl2).
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v1.0
In Commercial Distribution

  • 09355529000088 ()
-

  • MRI phantom, test object
Cardiovascular magnetic resonance (CMR) T2 mapping is key to quantifying myocardial inflammation. The T2CMR Phantom is made of nine (9) plastic tubes (30mL) containing different concentrations of nickel chloride (NiCl2) in agarose. T2CMR Phantom is provided to MRI Centres for the verification of T2-mapping stability across different 1.5T and 3T scanners (different manufacturers and models) and to understand the feasibility of delivering a “T2 standard”.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v1.0
In Commercial Distribution

  • 09355529000071 ()
-

  • MRI phantom, test object
The T1CMR Phantom contains a range of nickel chloride in agarose solutions that mimic cardiac T1 and T2 values. T1 measurement is used to calculate the extravascular volume fraction (ECV) to detect diffuse myocardial fibrosis. It is provided to MRI Centres for the verification of T1-mapping stability across different 3.0T scanners (different manufacturers and models) and to understand the feasibility of delivering a “T1 standard”.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v1.0
In Commercial Distribution

  • 09355529000064 ()
-

  • MRI phantom, test object
The T1CMR Phantom contains a range of nickel chloride in agarose solutions that mimic cardiac T1 and T2 values. T1 measurement is used to calculate the extravascular volume fraction (ECV) to detect diffuse myocardial fibrosis. It is provided to MRI Centres for the verification of T1-mapping stability across different 1.5T scanners (different manufacturers and models) and to understand the feasibility of delivering a “T1 standard”.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v1.0
In Commercial Distribution

  • 09355529000033 ()
-

  • MRI phantom, test object
Sealed pack containing 15 vials of varying concentrations (0 mM to 3.2 mM) of aqueous manganese chloride solutions in 10 mM hydrochloride acid solution. It is intended to be used for verification / re-verification of correct MRI scanner sequence configuration for the use of R2-MRI Analysis System (FerriScan)
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v1.0 (15 vials (0 to 3.2 mM))
In Commercial Distribution



  • MRI phantom, test object
Senti Desktop Flex Screening Set Content: 1. Case AN100503 2. Inlay Sentiero AN100385 3. Senti Desktop Flex device AN100433 4. Headphone DD-45 AN100306 5. FW Labelprinter AN100414 6. FW Pure Tone Audiometer Class 4 Advanced AN100653 7. Power supply AN100524 + AN100525-USA or AN101360 + 101251-USA optionally 8. USB data cable AN100418
PATH medical GmbH
100470-SC
In Commercial Distribution

  • 04260223145285 ()


  • Tone audiometer
Senti Audiometry (Class 4 Advanced) Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. Senti device with touchscreen AN100097 4. FW Labelprinter AN100414 5. Pure Tone Audiometer Class 4A AN100653 6. Headphone HDA-280 AN100117 7. Power supply AN100083 8. USB data cable AN100089
PATH medical GmbH
100330
Not in Commercial Distribution

  • 04260223143151 ()


  • Tone audiometer
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