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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This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes.
MINXRAY, INC.
CMDR.T.1202.R
In Commercial Distribution

  • 00858846007116 ()


  • Mobile basic diagnostic x-ray system, digital
This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes.
MINXRAY, INC.
CMDR.T.1202.S
In Commercial Distribution

  • 00858846007109 ()


  • Mobile basic diagnostic x-ray system, digital
This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes.
MINXRAY, INC.
CMDR.TW.100.S
In Commercial Distribution

  • 00858846007093 ()


  • Mobile basic diagnostic x-ray system, digital
This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes.
MINXRAY, INC.
CMDR.T.100.R
In Commercial Distribution

  • 00858846007086 ()


  • Mobile basic diagnostic x-ray system, digital
This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes.
MINXRAY, INC.
CMDR.PE.1202.R
In Commercial Distribution

  • 00858846007079 ()


  • Mobile basic diagnostic x-ray system, digital
This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes.
MINXRAY, INC.
CMDR.PE.100.S
In Commercial Distribution

  • 00858846007062 ()


  • Mobile basic diagnostic x-ray system, digital
This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes.
MINXRAY, INC.
CMDR.T.120.60.S
In Commercial Distribution

  • 00858846007055 ()


  • Mobile basic diagnostic x-ray system, digital
This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes.
MINXRAY, INC.
CMDR.T.120.60.R
In Commercial Distribution

  • 00858846007048 ()


  • Mobile basic diagnostic x-ray system, digital
This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes.
MINXRAY, INC.
CMDR-2SLWT
In Commercial Distribution

  • 00858846007031 ()


  • Mobile basic diagnostic x-ray system, digital
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-1000
In Commercial Distribution

  • 06938396410049 ()


  • Portable basic diagnostic x-ray system, digital
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2300T
In Commercial Distribution

  • 06938396400767 ()


  • Portable basic diagnostic x-ray system, digital
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2100S
In Commercial Distribution

  • 06938396400446 ()


  • Portable basic diagnostic x-ray system, digital
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2100
In Commercial Distribution

  • 06938396400439 ()


  • Portable basic diagnostic x-ray system, digital
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-1100S
In Commercial Distribution

  • 06938396400422 ()


  • Portable basic diagnostic x-ray system, digital
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-1100
In Commercial Distribution

  • 06938396400415 ()


  • Portable basic diagnostic x-ray system, digital
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2300S
In Commercial Distribution

  • 06938396423025 ()


  • Portable basic diagnostic x-ray system, digital
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2300
In Commercial Distribution

  • 06938396423018 ()


  • Portable basic diagnostic x-ray system, digital
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-1000S
In Commercial Distribution

  • 06938396410063 ()


  • Portable basic diagnostic x-ray system, digital
The Halifax Imaging Kit is part of the SR Suite product line, provides an alternative path to creating an SR Suite. The Halifax Imaging Kit is comprised of FDA cleared or certified X-Ray components integrated into an existing digital radiography room already containing an FDA cleared x-ray imaging system to form an SR Suite. The exposures of the Halifax Imaging Kit and the existing DR system are synchronized by replacing the trigger switches of the two systems with the Halifax Synchronization Switch. The Halifax Synchronization Switch ensures the two X-Ray imaging systems fire simultaneously, providing a pair of X-Ray images from two different perspectives to be taken at the exact same time. This process allows for Roentgen Stereophotogrammetric Analysis (RSA) or stereo orthopaedic radiography (SOR). RSA is a stereo x-ray technique that enables measurements more accurate and precise than single plane radiography based on phantom studies. The increased level of precision enables measurement of implant stability.
Halifax Biomedical Incorporated
1
In Commercial Distribution

  • 00628451892021 ()
P008943

  • Stationary basic diagnostic x-ray system, digital
The I-Q View is a software package to be used with FDA cleared solid-state imaging receptors. It functions as a diagnostic x-ray image acquisition platform and allows these images to be transferred to hard copy, softcopy, and archive devices via DICOM protocol.
First Source, Inc.
V5
In Commercial Distribution

  • G221200CA3080 ()
200-CA-308

  • Radiology DICOM image processing application software
No Description
NONAGON LTD
N9+
In Commercial Distribution

  • 27290018446151 ()


  • Pulse oximeter
  • Electronic acoustic stethoscope
  • Otoscope, direct
  • Infrared patient thermometer, skin
No Description
NONAGON LTD
N9+
In Commercial Distribution

  • 17290018446154 ()


  • Pulse oximeter
  • Electronic acoustic stethoscope
  • Otoscope, direct
  • Infrared patient thermometer, skin
The Nonagon N9 device is a home use device. The device is comprised of a handheld unit that connects with a smartphone and a dedicated smartphone software application that runs on the user's personal smartphone An API is defined to enable healthcare providers to communicate with the device. The Device enables user’s examination at home with or without the guidance of a remote physician. It also enables guidance and data examination by a remote physician over an IP network. The Smartphone Application controls the Handheld Unit's functionality and processes and displays the collected data. The N9 device measure, record, and transmit data of auscultation sound of human body (lung, hear, abdomen), temperature, oxygen saturation (SpO2) and pulse rate, and can be used to send images of an examined body part. In addition, the device includes otoscope where images of the ear can be transmitted to the healthcare provider.
NONAGON LTD
N9
In Commercial Distribution

  • 07290018446102 ()
  • 17290018446109 ()
MHD-100-02-001

  • Pulse oximeter
  • Electronic acoustic stethoscope
  • Otoscope, direct
  • Infrared patient thermometer, skin
TytoHome used for comprehensive remote exam and telehealth. This is a convenience kit containing the following DIs: 07290016672770 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672794 Tyto Stethoscope and 7290016672800 Tyto Otoscope. TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672760 when packed in 6 pack and with 27290016672767 when packed in 48 pack.
TYTO CARE LTD
TytoHome G2 US
In Commercial Distribution

  • 07290016672763 ()
900-00015-064

  • Multi-purpose digital medical camera
  • Otoscope, direct
  • Infrared patient thermometer, skin
  • Electronic acoustic stethoscope
TytoPro used for comprehensive remote exam and telehealth. This is a convenience kit containing the following DIs: 07290016672787 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672817 Tyto Stethoscope and 07290016672824 Tyto Otoscope. TytoPro kits are shipped to the US in a logistic carton labeled with DI 17290016672753 when packed in 6 pack and with 27290016672750 when packed in 48 pack.
TYTO CARE LTD
TytoPro G2
In Commercial Distribution

  • 07290016672756 ()
900-00002-062

  • Multi-purpose digital medical camera
  • Otoscope, direct
  • Infrared patient thermometer, skin
  • Electronic acoustic stethoscope
TytoHome used for comprehensive remote exam and telehealth. This is a convenience kit containing the following DIs: 07290016672473 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672404 Tyto Stethoscope and 07290016672411 Tyto Otoscope. TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672685 when packed in 6 pack and with 27290016672682 when packed in 48 pack .
TYTO CARE LTD
TytoHome G2 US
In Commercial Distribution

  • 17290016672685 ()
  • 07290016672688 ()
  • 27290016672682 ()
900-00015-063

  • Multi-purpose digital medical camera
  • Otoscope, direct
  • Infrared patient thermometer, skin
  • Electronic acoustic stethoscope
Designed for professional use, TytoPro used for comprehensive remote exam and telehealth. The TytoPro includes the Tyto Otoscope, Tyto Stethoscope, Tyto Exam Camera, Tyto Thermometer and disposable ear caps and tongue depressor blades. This is a convenience kit containing the following DIs: 07290016672534 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672343 Tyto Stethoscope and 07290016672350 Tyto Otoscope. TytoPro kits are shipped to the US in a 6 pack logistic carton labeled with DI 17290016672548 and 48 pack logistic carton labeled with 27290016672545.
TYTO CARE LTD
TytoPro G2 US
In Commercial Distribution

  • 07290016672541 ()
  • 17290016672548 ()
  • 27290016672545 ()
900-00002-007

  • Electronic acoustic stethoscope
  • Infrared patient thermometer, skin
  • Otoscope, direct
  • Multi-purpose digital medical camera
TytoHome used for comprehensive remote exam and telehealth. This is a convenience kit containing the following DIs: 07290016672473 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672404 Tyto Stethoscope and 07290016672411 Tyto Otoscope. TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672487 when packed in 6 pack and with 27290016672484 when packed in 48 pack .
TYTO CARE LTD
TytoHome G2 US
In Commercial Distribution

  • 17290016672487 ()
  • 07290016672480 ()
  • 27290016672484 ()
900-00015-004

  • Multi-purpose digital medical camera
  • Otoscope, direct
  • Infrared patient thermometer, skin
  • Electronic acoustic stethoscope
TytoHome used for comprehensive remote exam and telehealth. TytoCare device with high resolution video and still camera, non-touch infrared thermometer, stethoscope, otoscope and tongue depressor attachments. this is a convenience kit containing the following DIs: 07290016672336 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672404 Tyto Stethoscope and 07290016672411 Tyto Otoscope. TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672425 when packed in 6 pack and with 27290016672422 when packed in 48 pack .
TYTO CARE LTD
TytoHome US
In Commercial Distribution

  • 17290016672425 ()
  • 07290016672428 ()
  • 27290016672422 ()
900-00015-009

  • Multi-purpose digital medical camera
  • Otoscope, direct
  • Infrared patient thermometer, skin
  • Electronic acoustic stethoscope
TytoHome used for comprehensive remote exam and telehealth. TytoCare device with high resolution video and still camera, non-touch infrared thermometer, stethoscope, otoscope and tongue depressor attachments. this is a convenience kit containing the following DIs: 07290016672336 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672343 Tyto Stethoscope and 07290016672350 Tyto Otoscope. TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672302.
TYTO CARE LTD
TytoHome US
In Commercial Distribution

  • 17290016672302 ()
  • 07290016672305 ()
900-00015-006

  • Multi-purpose digital medical camera
  • Otoscope, direct
  • Infrared patient thermometer, skin
  • Electronic acoustic stethoscope
Designed for professional use, TytoPro used for comprehensive remote exam and telehealth. TytoCare device with high resolution video and still camera, no-touch infrared thermometer, stethoscope, otoscope and tongue depressor attachments. this is a convenience kit containing the following DIs: 07290016672367 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672343 Tyto Stethoscope and 07290016672350 Tyto Otoscope. TytoPro kits are shipped to the US in a 6 pack logistic carton labeled with DI 17290016672296 and 54 pack logistic carton labeled with 27290016672293.
TYTO CARE LTD
TytoPro US
In Commercial Distribution

  • 07290016672299 ()
  • 17290016672296 ()
  • 27290016672293 ()
900-00002-005

  • Electronic acoustic stethoscope
  • Infrared patient thermometer, skin
  • Otoscope, direct
  • Multi-purpose digital medical camera
TytoHome used for comprehensive remote exam and telehealth. TytoCare device with high resolution video and still camera, no-touch infrared basal thermometer, stethoscope, otoscope and tongue depressor attachments. this is a convenience kit containing the following DIs: 07290016672183 Tyto Device with Basal Thermometer and Exam Camera, 07290016672190 Tyto Stethoscope and 07290016672206 Tyto Otoscope. TytoHome kits are shipped to the US in a logistic carton labeled with 17290016672210.
TYTO CARE LTD
TytoHome
In Commercial Distribution

  • 07290016672213 ()
900-00015

  • Multi-purpose digital medical camera
  • Otoscope, direct
  • Infrared patient thermometer, skin
  • Electronic acoustic stethoscope
TytoHome used for comprehensive remote exam and telehealth. TytoCare device with high resolution video and still camera, no-touch infrared basal thermometer, stethoscope, otoscope and tongue depressor attachments. this is a convenience kit containing the following DIs: 07290016672008 TytoCare, 07290016672015 Tyto Stethoscope and 07290016672022 Tyto Otoscope. TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672050.
TYTO CARE LTD
TytoHome
In Commercial Distribution

  • 07290016672053 ()
  • 17290016672050 ()
900-00015

  • Electronic acoustic stethoscope
  • Infrared patient thermometer, skin
  • Otoscope, direct
  • Multi-purpose digital medical camera
Designed for professional use, TytoPro used for comprehensive remote exam and telehealth. TytoCare device with high resolution video and still camera, no-touch infrared basal thermometer, stethoscope, otoscope and tongue depressor attachments. this is a convenience kit containing the following DIs: 07290016672008 TytoCare, 07290016672015 Tyto Stethoscope and 07290016672022 Tyto Otoscope. TytoPro kits are shipped to the US in a logistic carton labeled with DI 17290016672036.
TYTO CARE LTD
TytoPro
In Commercial Distribution

  • 07290016672039 ()
  • 17290016672036 ()
900-00002

  • Multi-purpose digital medical camera
  • Otoscope, direct
  • Infrared patient thermometer, skin
  • Electronic acoustic stethoscope
SELECT TL3 toilet bracket, for wall outlet, 120V, white single molded cover. Electrically height adjustable with control panel (on support arm)
Pressalit A/S
R9143
In Commercial Distribution

  • 05708590372778 ()
R9143000

  • Height-adjustable toilet bracket, electric
SELECT TL3 toilet bracket, for wall outlet, 120V, anthracite single molded cover. Electrically height adjustable with control panel (on support arm)
Pressalit A/S
R9143
In Commercial Distribution

  • 05708590372761 ()
R9143112

  • Height-adjustable toilet bracket, electric
SELECT TL3 toilet bracket, for floor outlet, 120V, white single molded cover. Electrically height adjustable with control panel (on support arm)
Pressalit A/S
R9133
In Commercial Distribution

  • 05708590372693 ()
R9133000

  • Height-adjustable toilet bracket, electric
SELECT TL3 toilet bracket, for floor outlet, 120V, anthracite single molded cover. Electrically height adjustable with control panel (on support arm)
Pressalit A/S
R9133
In Commercial Distribution

  • 05708590372686 ()
R9133112

  • Height-adjustable toilet bracket, electric
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC) and Cocaine and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601587
Not in Commercial Distribution

  • 00690286000131 ()
  • 10690286000138 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The VITEK REVEAL SEALER provides the heat welding of the VITEK REVEAL SENSOR PANEL to the 96 well AST Drug Plate.
BIOMERIEUX , INC.
900-00003
In Commercial Distribution

  • 00860007326912 ()


  • Package sealing unit
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