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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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UNITY - 18257200032594

SCREW, 1/4-28 LOCKING ANTERIOR LUMBAR SYSTEM NEW P/N 90-1481
Orthofix US LLC
43-6001
In Commercial Distribution

  • 18257200032594 ()


  • Spinal fixation plate, non-bioabsorbable

Unimed - 06945664899673

Blood oxygen connection /Spacelabs- Masmo / 2.2m /072+170/Nellcor/NEW Partssource
Unimed Medical Supplies, Inc.
U708N-74MR
In Commercial Distribution

  • 06945664899673 ()


  • Electrical-only medical device connection cable, reusable

Unimed - 06945664896283

Blood oxygen cable/Marquette-Masmo/2.2M/064+172/Masmo LNCS/NEW Partssource
Unimed Medical Supplies, Inc.
U708M-21R(NPS)
In Commercial Distribution

  • 06945664896283 ()


  • Electrical-only medical device connection cable, reusable

Unimed - 06945664888615

Reusable SpO2 Sensor/GE TruSignal/New lift finger clip/Adult/1.1M
Unimed Medical Supplies, Inc.
U403NC-117
In Commercial Distribution

  • 06945664888615 ()


  • Pulse oximeter probe, reusable

BAUM - 00810010923486

Screws (New Style to attach Scale to Reservoir on Standby Model
W. A. BAUM CO., INC.
2272NS
In Commercial Distribution

  • 00810010923486 ()
2272NS

  • Aneroid manual sphygmomanometer

ARTERIAL LINE DRESSING CHANGE KIT - M752HCT900CHX0

PREP INF DOSE NEW OR REPLACEMENT DRESSING AND FLUSING OF LINE
STRADIS MEDICAL LLC
HCT900CHX
In Commercial Distribution

  • M752HCT900CHX0 ()
  • M752HCT900CHX5 ()


  • Vascular catheterization support/maintenance kit, non-medicated

Unimed - 06945664896306

Repetitive SpO2 Probe/Philips/Ear Clip/Adult/1.1M/087/NEW Partssource
Unimed Medical Supplies, Inc.
U903-91(NPS)
In Commercial Distribution

  • 06945664896306 ()


  • Pulse oximeter probe, reusable

Unimed - 06945664896290

Repetitive SpO2 Probe/Nellcor-OXIMAX/Ear Clip/Adult/1.1M/103X/NEW Partssource
Unimed Medical Supplies, Inc.
U903-01P(NPS)
In Commercial Distribution

  • 06945664896290 ()


  • Pulse oximeter probe, reusable

JointVue jFit - 00850014885021

jFit Software
JOINTVUE, LLC
1.0
Not in Commercial Distribution

  • 00850014885021 ()


  • Ultrasound imaging system application software

AI4CMR - 05600250059022

AI4CMR v1.0 is a cloud-hosted service used with any third-party DICOM viewer applicationwhere the DICOM viewer serves as the user interface and the interface to a PACS or scanner forAI4CMR. AI4CMR is implemented as a plug-in to the DICOM viewer by the user andautomatically processes and analyses cardiac MR images received by the DICOM viewer toquantify relevant cardiac function metrics and makes the information available to the user at theuser’s discretion Indications for use: AI4CMR software is designed to report cardiac function measurements (ventricle volumes, ejection fraction, indices etc.) from 1.5T and 3T magnetic resonance (MR) scanners. AI4CMR uses artificial intelligence to automatically segment and quantify the different cardiac measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making. The user incorporating AI4CMR into their DICOM application of choice is responsible for implementing a user interface.
AI4MEDIMAGING - MEDICAL SOLUTIONS, S.A.
v1.0
In Commercial Distribution

  • 05600250059022 ()


  • MRI system application software
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