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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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SynGen® DataTrak - B039SGI07770

The SynGen™ DataTrak software is the application code that provides the interface between the operator and the SynGenX™-1000 System through a host PC computer. It downloads processing and system information from the CM and stores it in a database on the host PC computer. The data collected includes information gathered during each buffy coat harvest run including output of the accelerometer, infrared sensor readings, and timing and duration of the pinch and release of the cell transfer tubes. This collected data serves to document each processing run of the cord blood to support cGMP compliance.
Thermogenesis Corp.
SGI-0777
In Commercial Distribution

  • B039SGI07770 ()


  • Blood centrifugation system application software

Minuteful for Wound at Home - 17290017272877

The Minuteful for Wound device is a comprehensive wound management system designed to assist in the management of chronic wounds. It is intended to support healthcare professionals in the clinical assessment of wounds by measuring, documenting, monitoring, and managing information relevant to the progression and treatment of chronic wounds. The device comprises Calibration Stickers, a Web Portal for healthcare professionals to review and manage wound data, and two separate smartphone applications. These applications are utilized for the collection of wound data: one for healthcare professionals and one for lay users under the guidance and supervision of healthcare professionals.
HEALTHY.IO LTD
WND PNT.EN.GEN
In Commercial Distribution

  • 07290017272504 ()
  • 17290017272877 ()


  • Wound management image-analysis software

Minuteful for Wound - 17290017272716

The Minuteful for Wound device is a comprehensive wound management system designed to assist in the management of chronic wounds. It is intended to support healthcare professionals in the clinical assessment of wounds by measuring, documenting, monitoring, and managing information relevant to the progression and treatment of chronic wounds. The device comprises Calibration Stickers, a Web Portal for healthcare professionals to review and manage wound data, and two separate smartphone applications. These applications are utilized for the collection of wound data: one for healthcare professionals and one for lay users under the guidance and supervision of healthcare professionals.
HEALTHY.IO LTD
MNT WND.EN.GN2
In Commercial Distribution

  • 07290017272504 ()
  • 17290017272716 ()


  • Wound management image-analysis software

Minuteful for Wound - 17290017272709

The Minuteful for Wound device is intended to provide healthcare professionals with a tool to document, track, and monitor chronic wounds which will aid in wound care management.
HEALTHY.IO LTD
MNT WND.EN.GEN
In Commercial Distribution

  • 07290017272504 ()
  • 17290017272709 ()


  • Wound management image-analysis software

SPOT - 17290017272556

The SPOT device is intended to provide healthcare professionals with a tool to document, track, and monitor chronic wounds which will aid in wound care management.
HEALTHY.IO LTD
SPOT.EN.G25
In Commercial Distribution

  • 07290017272504 ()
  • 17290017272556 ()


  • Wound management image-analysis software

SPOT - 17290017272501

The SPOT device is intended to provide healthcare professionals with a tool to document, track, and monitor chronic wounds which will aid in wound care management.
HEALTHY.IO LTD
SPOT.EN.GEN
In Commercial Distribution

  • 17290017272501 ()
  • 07290017272504 ()


  • Wound management image-analysis software

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

Rapid - B761R610

Rapid System Update
Ischemaview, Inc.
6.1.0
In Commercial Distribution

  • B761R610 ()


  • Radiological PACS software

Rapid - B761R60

Rapid Platform plus cleared indications for Rapid version 6.x
Ischemaview, Inc.
6.x
In Commercial Distribution

  • B761R60 ()


  • Radiological PACS software

Propeller - 00859105006321

The convenience kit contains the following products: Propeller Sensor Model 2016-M-L (GTIN-14: 00865528000082) Propeller Sensor Model 2016-M-S (GTIN-14: 00865528000075) Qualcomm 2Net Hub (GTIN-14: 0100857803004014)
RECIPROCAL LABS CORPORATION
Convenience Kit - HUB/SM2016ML/SM2016MS
In Commercial Distribution

  • 00859105006321 ()


  • Inhaler dose sensor

Propeller - 00859105006307

The convenience kit contains the following products: Propeller Sensor Model 2016-M-L (GTIN-14: 00865528000082) Propeller Sensor Model 2015-E (GTIN-14: 00865528000068) Qualcomm 2Net Hub (GTIN-14: 00857803004014)
RECIPROCAL LABS CORPORATION
Convenience Kit - HUB/SM2016ML/SM2015E
In Commercial Distribution

  • 00859105006307 ()


  • Inhaler dose sensor

Propeller - 00859105006277

The convenience kit contains the following products: Propeller Sensor Model 2016-M-L (GTIN-14: 00865528000082) Propeller Sensor Model 2016-M-S (GTIN-14: 00865528000075)
RECIPROCAL LABS CORPORATION
Convenience Kit - Mobile/SM2016ML/SM2016MS
In Commercial Distribution

  • 00859105006277 ()


  • Inhaler dose sensor

Propeller - 00859105006260

The convenience kit contains the following products: 2 x Propeller Sensor Model 2016-M-L (GTIN-14: 00865528000082)
RECIPROCAL LABS CORPORATION
Convenience Kit - Mobile/SM2016ML/SM2016ML
In Commercial Distribution

  • 00859105006260 ()


  • Inhaler dose sensor

Propeller - 00859105006246

The convenience kit contains the following products: Propeller Sensor Model 2016-M-L (GTIN-14: 00865528000082) Propeller Sensor Model 2014-D (GTIN-14: 00865528000037)
RECIPROCAL LABS CORPORATION
Convenience Kit - Mobile/SM2016ML/SM2014D
In Commercial Distribution

  • 00859105006246 ()


  • Inhaler dose sensor

Propeller - 00859105006239

The convenience kit contains the following products: Propeller Sensor Model 2016-M-L (GTIN-14: 00865528000082) Propeller Sensor Model 2014-R (GTIN-14: 00865528000020)
RECIPROCAL LABS CORPORATION
Convenience Kit - Mobile/SM2016ML/SM2014R
In Commercial Distribution

  • 00859105006239 ()


  • Inhaler dose sensor

Propeller - 00859105006222

The convenience kit contains the following products: Propeller Sensor Model 2016-M-L (GTIN-14: 00865528000082) Propeller Sensor Model 2015-E (GTIN-14: 00865528000068)
RECIPROCAL LABS CORPORATION
Convenience Kit - Mobile/SM2016ML/SM2015E
In Commercial Distribution

  • 00859105006222 ()


  • Inhaler dose sensor

Propeller - 00859105006215

The convenience kit contains the following products: Propeller Sensor Model 2016-M-S: (GTIN-14: 00865528000075) Qualcomm 2Net Hub (GTIN-14: 0100857803004014)
RECIPROCAL LABS CORPORATION
Convenience Kit - HUB/SM2016MS
In Commercial Distribution

  • 00859105006215 ()


  • Inhaler dose sensor

Propeller - 00859105006208

The convenience kit contains the following products: Two (2) x Propeller Sensor Model 2016-M-S devices (GTIN-14: 00865528000075) Qualcomm 2Net Hub (GTIN-14: 0100857803004014)
RECIPROCAL LABS CORPORATION
Convenience Kit - HUB/SM2016MS/SM2016MS
In Commercial Distribution

  • 00859105006208 ()


  • Inhaler dose sensor

Propeller - 00859105006192

The convenience kit contains the following products: Propeller Sensor Model 2016-M-S (GTIN-14: 00865528000075) Propeller Sensor Model 2015-E (GTIN-14: 00865528000068) Qualcomm 2Net Hub (GTIN-14: 0100857803004014)
RECIPROCAL LABS CORPORATION
Convenience Kit - HUB/SM2016MS/SM2015E
In Commercial Distribution

  • 00859105006192 ()


  • Inhaler dose sensor

Propeller - 00859105006185

The convenience kit contains the following products: Propeller Sensor Model 2016-M-S (GTIN-14: 00865528000075) Propeller Sensor Model 2014-D (GTIN-14: 00865528000037) Qualcomm 2Net Hub (GTIN-14: 0100857803004014)
RECIPROCAL LABS CORPORATION
Convenience Kit - HUB/SM2016MS/SM2014D
In Commercial Distribution

  • 00859105006185 ()


  • Inhaler dose sensor

Propeller - 00859105006178

The convenience kit contains the following products: Propeller Sensor Model 2016-M-S (GTIN-14: 00865528000075) Propeller Sensor Model 2014-R (GTIN-14: 00865528000020) Qualcomm 2Net Hub (GTIN-14: 0100857803004014)
RECIPROCAL LABS CORPORATION
Convenience kit - HUB/SM2016MS/SM2014R
In Commercial Distribution

  • 00859105006178 ()


  • Inhaler dose sensor

Propeller - 00859105006161

The convenience kit contains the following products: (2x) Propeller Sensor Model 2016-M-S (GTIN-14: 00865528000075)
RECIPROCAL LABS CORPORATION
Convenience Kit - Mobile/SM2016MS/SM2016MS
In Commercial Distribution

  • 00859105006161 ()


  • Inhaler dose sensor

Propeller - 00859105006147

The convenience kit contains the following products: Propeller Sensor Model 2016-M-S (GTIN-14: 00865528000075) Propeller Sensor Model 2015-E (GTIN-14: 00865528000068)
RECIPROCAL LABS CORPORATION
Convenience Kit - Mobile/SM2016MS/SM2015E
In Commercial Distribution

  • 00859105006147 ()


  • Inhaler dose sensor

Propeller - 00859105006130

The convenience kit contains the following products: Propeller Sensor Model 2016-M-S (GTIN-14: 00865528000075) Propeller Sensor Model 2014-D (GTIN-14: 00865528000037)
RECIPROCAL LABS CORPORATION
Convenience Kit - Mobile/SM2016MS/SM2014D
In Commercial Distribution

  • 00859105006130 ()


  • Inhaler dose sensor

Propeller - 00859105006123

The convenience kit contains the following products: Propeller Sensor Model 2016-M-S (GTIN-14: 00865528000075) Propeller Sensor Model 2014-R (GTIN-14: 00865528000020)
RECIPROCAL LABS CORPORATION
Convenience Kit - Mobile/SM2016MS/SM2014R
In Commercial Distribution

  • 00859105006123 ()


  • Inhaler dose sensor

Propeller - 00859105006116

The convenience kit contains the following products: Propeller Sensor Model 2015-E (GTIN-14: 00865528000068) Qualcomm 2Net Hub (GTIN-14: 0100857803004014)
RECIPROCAL LABS CORPORATION
Convenience Kit - Hub/SM2015-E
In Commercial Distribution

  • 00859105006116 ()


  • Inhaler dose sensor

Propeller - 00859105006109

Contains the following products Propeller Sensor Model 2014-D (GS1 GTIN-12: 00865528000037) Qualcomm 2Net Hub (GS1 GTIN-12: 00857803004014)
RECIPROCAL LABS CORPORATION
Convenience Kit - HUB/SM2014-D
In Commercial Distribution

  • 00859105006109 ()


  • Inhaler dose sensor

Propeller - 00859105006093

Convenience Kit Contains the following products: Propeller Sensor Model 2014-R (GTIN-14: 00865528000020) Qualcomm 2Net Hub (GTIN-14: 0100857803004014)
RECIPROCAL LABS CORPORATION
Convenience Kit - HUB/SM2014-R
In Commercial Distribution

  • 00859105006093 ()


  • Inhaler dose sensor

Propeller - 00859105006086

The convenience kit contains the following products: Propeller Sensor Model II (GTIN-14: 00865528000006) Qualcomm 2Net Hub (GTIN-14: 0100857803004014)
RECIPROCAL LABS CORPORATION
Convenience Kit - HUB/SMII
In Commercial Distribution

  • 00859105006086 ()


  • Inhaler dose sensor

Propeller - 00859105006079

The convenience kit contains the following products: Propeller Sensor Model II (GTIN-14: 00865528000006) Propeller Sensor Model 2015-E (GTIN-14: 00865528000068) Qualcomm 2Net Hub (GTIN-14: 00857803004014)
RECIPROCAL LABS CORPORATION
Convenience Kit - HUB/SMII/SM2015-E
In Commercial Distribution

  • 00859105006079 ()


  • Inhaler dose sensor

Propeller - 00859105006062

The convenience kit contains the following products: Propeller Sensor Model II (GTIN-14: 00865528000006) Propeller Sensor Model 2014-D (GTIN-14: 00865528000037) Qualcomm 2Net Hub (GTIN-14: 0100857803004014)
RECIPROCAL LABS CORPORATION
Convenience Kit - HUB/SMII/SM2014-D
In Commercial Distribution

  • 00859105006062 ()


  • Inhaler dose sensor

Propeller - 00859105006055

The convenience kit contains the following products: Propeller Sensor Model II (GTIN-14: 00865528000006) Propeller Sensor Model 2014-R (GTIN-14: 00865528000020) Qualcomm 2Net Hub (GTIN-14: 0100857803004014)
RECIPROCAL LABS CORPORATION
Convenience Kit - HUB/SMII/SM2014-R
In Commercial Distribution

  • 00859105006055 ()


  • Inhaler dose sensor

Propeller - 00859105006048

The convenience kit contains the following products: 2 x Propeller Sensor Model II (GTIN-14: 00865528000006) Qualcomm 2Net Hub (GTIN-14: 0100857803004014)
RECIPROCAL LABS CORPORATION
Convenience Kit - HUB/SMII/SMII
In Commercial Distribution

  • 00859105006048 ()


  • Inhaler dose sensor

Propeller - 00859105006031

The convenience kit contains the following products: Propeller Sensor Model II (GTIN-14: 00865528000006) Propeller Sensor Model 2015-E (GTIN-14: 00865528000068)
RECIPROCAL LABS CORPORATION
Convenience Kit - Mobile/SMII/SM2015-E
In Commercial Distribution

  • 00859105006031 ()


  • Inhaler dose sensor

Propeller - 00859105006024

The convenience kit contains the following products: Propeller Sensor Model II (GTIN-14: 00865528000006) Propeller Sensor Model 2014-D (GTIN-14: 00865528000037)
RECIPROCAL LABS CORPORATION
Convenience Kit - Mobile/SMII/SM2014-D
In Commercial Distribution

  • 00859105006024 ()


  • Inhaler dose sensor

Propeller - 00859105006017

The convenience kit contains the following products: Propeller Sensor Model II (GTIN-14: 00865528000006) Propeller Sensor Model 2014-R (GTIN-14: 00865528000020)
RECIPROCAL LABS CORPORATION
Convenience Kit - Mobile/SMII/SM2014-R
In Commercial Distribution

  • 00859105006017 ()


  • Inhaler dose sensor

Propeller - 00859105006000

The convenience kit contains the following products: 2 x Propeller Sensor Model II (GTIN-14: 00865528000006)
RECIPROCAL LABS CORPORATION
Convenience Kit - Mobile/SMII/SMII
In Commercial Distribution

  • 00859105006000 ()


  • Inhaler dose sensor

TRITON - 00859506006173

TRITON AI
STRYKER CORPORATION
GAUS-6
In Commercial Distribution

  • 00859506006173 ()
GAUS-6

  • Blood loss estimation application software

Triton Sponge System- NUI Sensor Bracket - 00859506006098

NUI Sensor Bracket for Tryten Cart
STRYKER CORPORATION
PN 11028
In Commercial Distribution

  • 00859506006098 ()


  • Blood loss estimation application software

TRITON - 00859506006067

TRITON SPONGE
STRYKER CORPORATION
GAUS-3
In Commercial Distribution

  • 00859506006067 ()
GAUS-3

  • Blood loss estimation application software

Triton System (Sponge) - 00859506006050

No Description
STRYKER CORPORATION
GAUS-01
Not in Commercial Distribution

  • 00859506006050 ()


  • Blood loss estimation application software

TRITON - 00859506006029

TRITON CANISTER
STRYKER CORPORATION
GAUS-2
In Commercial Distribution

  • 00859506006029 ()
GAUS-2

  • Blood loss estimation application software

Propeller - 00859105006345

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

Propeller - 00859105006338

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

Propeller - 00859105006314

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

Propeller - 00859105006291

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

Propeller - 00859105006284

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

3Shape Implant Studio - 05902768365306

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

Implant Studio - 05902729753845

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
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