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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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MANI CARBIDE BURS
MANI, INC.
2
In Commercial Distribution

  • 74546951534379 ()
  • 04546951534370 ()


  • Carbide dental bur, reusable
31-115 TMT Tourniquet 1.00EA GLOVES-2.00.101 Synmax, Blue, Industrial Grade, Powered Free, Latex Free 1.00 PR 30-212 MARCH Celox Rapid B-CON 3"x2' OTC 1.00EA 11-100-QR-EN POSTIONAL AIRWAY - ENGLISH 2.00 1.00EA L-SDR-VSIP-OTC-REFILSDR Vehicle Kit - OTC-Refill Insert 1.00EA 20-001-KOI Sentinel Chest Seal 2.00 1.00EA FCP-01 ETD 1.00EA BPS-47 Blizzard IFAK 1.00EA 95-000-QR-EN MARCH Cover QR Card - English 1.00EA 31-115-QR-EN TMT - ENGLISH 1.00EA 30-212-QR-EN CELOX RAPID B-CON - ENGLISH 1.00EA 20-001-QR-EN SENTINEL CHEST SEAL - ENGLISH 1.00EA 32-150-QR-EN COMPRESSION DRESSING - ENGLISH 1.00EA 04-101-QR-EN EMERGENCY BLANKET - ENGLISH 1.00EA P81-111 Snap Ring, 1/2" ID, Acetal (.55/13.5mm ID) 1.00EA L01-00 33x1 blank polypropylene TT label 1.00EA P81-250-07 Inner Pouch, PA Kit 7x1 1.00EA P59-100 Inner Pouch, Hypothermia Kit 1.00EA
Safeguard US Operating, LLC
2
In Commercial Distribution

  • M689SDRVSIPOTCREFILL020 ()
SDR-VSIP-OTC

  • First aid kit, non-medicated, single-use
Blizzard Blanket with Heat Pads
Safeguard US Operating, LLC
2
In Commercial Distribution

  • M689BH01020 ()
BH-01

  • Bed blanket, single-use
  • Hot/cold therapy pack, single-use
No Description
GE MEDICAL SYSTEMS, INC.
2
In Commercial Distribution

  • 00840682142601 ()


  • CT system application software
Sonio Detect is a Software as a Service SaaS solution that aims at helping sonographers, OB/GYN MFMs and Fetal surgeons (all three designated as healthcare professionals i.e. HCP in the following) to perform their routine fetal ultrasound examinations in real-time. Sonio Detect can be used by Healthcare Professionals HCPs during fetal ultrasound exams for Trimester 1, Trimester 2 and Trimester 3 of the fetus (GA: from 11 weeks to 37 weeks). The software is intended to assist HCPs in assuring during and after their examination that the examination is complete and all images were collected according to their protocol. Sonio Detect receives fetal ultrasound images and clips from the ultrasound machine, that are submitted through the edge software by the performing healthcare professional, in real-time and performs the following: Automatically detect views; Automatically detect anatomical structures within the supported views; Automatically verify quality criteria of the supported views by checking whether they conform to standardized quality criteria
SONIO
2
In Commercial Distribution

  • 03770024341041 ()


  • Ultrasound imaging system application software
SONIO Pro is intended to be used by healthcare professionals HCP during OB/GYN exams. It is a software connected to the Ultrasound equipment through a Sonio Edge Software installed in the HCP network that can send and upload media sent by the Ultrasound equipments in DICOM format, act as a Worklist for those Ultrasound equipments as well as interact with the IT solutions of the HCP through HL7 protocol (interoperability with the EMR, Billing System, ...) .
SONIO
2
In Commercial Distribution

  • 03770024341010 ()


  • Medical image management system
Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult only. Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types. (Variant : Cloud/VM)
AZMED
2
In Commercial Distribution

  • 03770018071022 ()


  • X-ray image interpretive software
Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult only. Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types. (Variant : Full Cloud)
AZMED
2
In Commercial Distribution

  • 03770018071015 ()


  • X-ray image interpretive software
Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult only. Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types. (Variant : On premise)
AZMED
2
In Commercial Distribution

  • 03770018071008 ()


  • X-ray image interpretive software
No Description
LUCERNO DYNAMICS, LLC
2
In Commercial Distribution

  • 00850014578268 ()
  • 00850014578091 ()
401874-200

  • Scintillation-counter radiation survey meter
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