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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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TRITON CANISTER
STRYKER CORPORATION
GAUS-2
In Commercial Distribution

  • 00859506006029 ()
GAUS-2

  • Blood loss estimation application software
The Propeller System includes the Propeller Sensor Model 2018-S. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed pMDI usage for the Symbicort device. The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from the pMDI sensor, and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician, and healthcare providers. The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their pMDI and its use, to capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians, and health care providers. When used with a prescribed pMDI, the system can report on information captured during the normal course of use, such as the time between actuations that can be helpful in assessing pMDI technique. The Propeller System is intended to be used in populations from Child (>2 years) to Adult. The Propeller System can be used both indoors and outdoors; home, work, and clinical settings, as well as on aircraft. The Propeller System may also be used in clinical trials where researchers need to know information about the use of pMDI medication(s) by a participant. The output of the Propeller System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The Propeller System is not intended for use as an pMDI dose counter, nor is it intended to indicate the quantity of medication remaining in an pMDI.
RECIPROCAL LABS CORPORATION
Sensor Model 2018-S
In Commercial Distribution

  • 00859105006345 ()


  • Inhaler dose sensor
The convenience kit contains the following products: Propeller Sensor Model 2016-M-L (GTIN-14: 00865528000082) Qualcomm 2Net Hub (GTIN-14: 0100857803004014)
RECIPROCAL LABS CORPORATION
Convenience Kit - HUB/SM2016ML
In Commercial Distribution

  • 00859105006338 ()


  • Inhaler dose sensor
The convenience kit contains the following products: 2 x Propeller Sensor Model 2016-M-L (GTIN-14: 00865528000082) Qualcomm 2Net Hub (GTIN-14: 0100857803004014)
RECIPROCAL LABS CORPORATION
Convenience Kit - HUB/SM2016ML/SM2016ML
In Commercial Distribution

  • 00859105006314 ()


  • Inhaler dose sensor
The convenience kit contains the following products: Propeller Sensor Model 2016-M-L (GTIN-14: 00865528000082) Propeller Sensor Model 2014-D (GTIN-14: 00865528000037) Qualcomm 2Net Hub (GTIN-14: 0100857803004014)
RECIPROCAL LABS CORPORATION
Convenience Kit - HUB/SM2016ML/SM2014D
In Commercial Distribution

  • 00859105006291 ()


  • Inhaler dose sensor
The convenience kit contains the following products: Propeller Sensor Model 2016-M-L (GTIN-14: 00865528000082) Propeller Sensor Model 2014-R (GTIN-14: 00865528000020) Qualcomm 2Net Hub (GTIN-14: 0100857803004014)
RECIPROCAL LABS CORPORATION
Convenience Kit - HUB/SM2016ML/SM2014R
In Commercial Distribution

  • 00859105006284 ()


  • Inhaler dose sensor
IMPLANT STUDIO IPGS (Implant Planning and Surgical Guide) is intended to be used as pre-operative planning soft-ware to plan the placement of one or more implants based on an imported CBCT scan and optionally aligned with a loaded 3D surface scan. The implants are provided by a secured implant library. In addition Virtual Crowns can be used for optimized implant positioning under the esthetical aspect. Further a surgical guide for a guided surgery can be designed and exported for 3rd party fabrication based on the approved implant position. The use of the software requires to have the necessary expertise in implant dentistry.The IMPLANT STUDIO IPGS system must be operated by trained dental practitioners and dental technicians who are skilled in implant dentistry.The IMPLANT STUDIO IPGS software is to be used in general dentist clinics and dental laboratories.
3shape Medical A/S
2016-1
Not in Commercial Distribution

  • 05902768365306 ()


  • Dental treatment application software
3Shape Implant Studio® is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in dental implantology and surgical dentistry. This software reads imaging information output from medical scanners such as CT and optical scanners. It allows pre-operative simulation and evaluation of patient anatomy and dental implant placement. Surgical guides and the planned implant position can be exported as 3D models and the guides can be manufactured using said 3D models when used as input to 3D manufacturing systems.
3shape A/S
R1.4
In Commercial Distribution

  • 05902729753845 ()


  • Dental treatment application software
3Shape Implant Studio® is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in dental implantology and surgical dentistry. This software reads imaging information output from medical scanners such as CT and optical scanners. It allows pre-operative simulation and evaluation of patient anatomy and dental implant placement. Surgical guides and the planned implant position can be exported as 3D models and the guides can be manufactured using said 3D models when used as input to 3D manufacturing systems.
3shape A/S
R1.3
In Commercial Distribution

  • 05902729753692 ()


  • Dental treatment application software
Model 2017-B. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed DPI usage for Neohaler® devices. • The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from the DPI sensor, and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician, and healthcare providers. • The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their DPI and its use, to capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians, and health care providers. • When used with a prescribed DPI, the system can report on information captured during the normal course of use, such as the time between actuations that can be helpful in assessing DPI technique. • The Propeller System is intended to be used in populations from Child (>2 years) to Adult. • The Propeller System can be used both indoors and outdoors; home, work, and clinical settings, as well as on aircraft. • The Propeller System may also be used in clinical trials where researchers need to know information about the use of DPI medication(s) by a participant. • The output of the Propeller System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The Propeller System is not intended for use as an DPI dose counter, nor is it intended to indicate the quantity of medication remaining in an DPI.
RECIPROCAL LABS CORPORATION
Sensor Model 2017-B
In Commercial Distribution

  • 00865528000099 ()


  • Inhaler dose sensor
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