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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Beluga1 Imaging Probe
Tissue Differentiation Intelligence LLC
100005
In Commercial Distribution

  • 00860001239348 ()


  • Surgical ultrasound imaging transducer
SonoVision Accessory Kit Dilator Guide - Triple
Tissue Differentiation Intelligence LLC
100022
In Commercial Distribution

  • 00860001239331 ()


  • Interventional radiology percutaneous-access kit, reusable
SonoVision Accessory Kit Stabilzer Tube
Tissue Differentiation Intelligence LLC
100021
In Commercial Distribution

  • 00860001239324 ()


  • Interventional radiology percutaneous-access kit, reusable
Compact PERINE Probe. Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3D mapping, for urology application. Frequencies: 4-9 MHz Field of view 72 mm Scanning angle 170°
KOELIS
K3DEL00-2
In Commercial Distribution

  • 03665134000851 ()
  • 03665134000844 ()
K3DEL00-2

  • General-purpose ultrasound imaging system
Surface 2D probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gynecology, Musculoskeletal, small organs, soft tissues, urology and vascular applications Frequencies: 7-15MHz Field of view 40 mm
KOELIS
K2DLN00
In Commercial Distribution

  • 03665134000530 ()
  • 03665134000103 ()


  • General-purpose ultrasound imaging system
Surface 2D probe (Convex) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gynecology, Musculoskeletal, soft tissues, Urology and Vascular applications Frequencies: 2-5MHz Field of view 460° Radius 60 mm
KOELIS
K2DAB00
In Commercial Distribution

  • 03665134000523 ()
  • 03665134000097 ()


  • General-purpose ultrasound imaging system
Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3D mapping, for urology application. Frequencies: 4-9 MHz Field of view 72 mm Scanning angle 170°
KOELIS
K3DEL00
In Commercial Distribution

  • 03665134000516 ()
  • 03665134000080 ()


  • General-purpose ultrasound imaging system
Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3D mapping, for urology and gynecology applications. Frequencies: 4-9 MHz Field of view 146° Scanning angle 90° Radius 10 mm
KOELIS
K3DEC00-2
In Commercial Distribution

  • 03665134000509 ()
  • 03665134000073 ()


  • General-purpose ultrasound imaging system
Display Workstation
ST. JUDE MEDICAL, INC.
PN-004711
In Commercial Distribution

  • 07640157990316 ()
PN-004711

  • Cardiac mapping system computer
Quartz Equipment
ST. JUDE MEDICAL, INC.
PN-004400
In Commercial Distribution

  • 07640157990194 ()
PN-004400

  • Cardiac mapping system computer
No Description
SEBIA
4757
In Commercial Distribution

  • 03607360047576 ()
4757

  • Haemoglobin detection IVD, control
MICROPLATES ARE AN ACCESSORY _PLASTIC PLATES
SEBIA
2578
In Commercial Distribution

  • 03607360025789 ()
2578

  • Microplate IVD
No Description
SEBIA
2563
In Commercial Distribution

  • 03607360025635 ()
2563

  • Multiple haemoglobin subtype IVD, kit, electrophoresis
Diacap® Ultra Dialysis Fluid Filters
B.Braun Avitum AG
7107367
Not in Commercial Distribution

  • 04039239090496 ()
  • 04039239090489 ()
7107367

  • Haemodialysis system dialysate pyrogen filter
DIACAP ULTRA DF FILTER CA & US
B.Braun Avitum AG
7107368
In Commercial Distribution

  • 04046963178109 ()
  • 04046963178116 ()
7107368

  • Haemodialysis system dialysate pyrogen filter
No Description
Stockert GmbH
20403
In Commercial Distribution

  • 04260166374094 ()
M004GEN100204030

  • Cardiac radio-frequency ablation system generator
No Description
Stockert GmbH
20402
In Commercial Distribution

  • 04260166374087 ()
M004GEN100204020

  • Bedside infusion pump, single-channel
No Description
Stockert GmbH
20401
In Commercial Distribution

  • 04260166374070 ()
M004GEN100204010

  • Cardiac radio-frequency ablation system generator
No Description
Stockert GmbH
20010
In Commercial Distribution

  • 04260166373066 ()
M004GEN100200100

  • Foot-switch, electrical
CANNULA 77424 EOPA BLUNT 24FR 10PK 11L
MEDTRONIC, INC.
77424
In Commercial Distribution

  • 00763000946791 ()
  • 20763000946795 ()

  • Catheter Gauge: 24.0 French


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
No Description
MEDEX
QIT013
In Commercial Distribution

  • 13700550400971 ()
  • 23700550400978 ()
  • 33700550400975 ()


  • General-purpose syringe, single-use
Qitexio(R) 4-Way Stopcock is intended to serve as a flow control and delivery device for I.V. fluids injection to the patient's vascular system. Qitexio 4-Way Stopcock is not intended to facilitate bi-directional flows, thus is not designed to be used in infusion. Qitexio 4-Way Stopcock is designated for single use only (disposable) and is MR safe. Qitexio 4-Way Stopcock is robust under medium pressure and is verified to be used for Lipiodol (Ethiodized oil) delivery.
MEDEX
QIT014
In Commercial Distribution

  • 33700550400760 ()
  • 23700550400763 ()
  • 13700550400766 ()


  • Stopcock
3 ml Luer Lock Syringe
MEDEX
QIT012
In Commercial Distribution

  • 33700550400746 ()
  • 23700550400749 ()
  • 13700550400742 ()


  • General-purpose syringe, single-use
1 ml Luer Lock Syringe
MEDEX
QIT011
In Commercial Distribution

  • 33700550400739 ()
  • 23700550400732 ()
  • 13700550400735 ()


  • General-purpose syringe, single-use
Resectoscopic System, Outer Sheath, Rotatable, 27 Fr.
Ethicon Inc.
01939
Not in Commercial Distribution

  • 10705031000964 ()
01939

  • Endoscope sheath, reusable
Resectoscopic System, Hysteroscope 4.0mm 12°, High Magnification
Ethicon Inc.
01938
Not in Commercial Distribution

  • 10705031000957 ()
01938

  • Rigid optical hysteroscope
Resectoscopic System, Hysteroscope 4.0mm 30°, Wide Angle
Ethicon Inc.
01936
Not in Commercial Distribution

  • 10705031000940 ()
01936

  • Rigid optical hysteroscope
Resectoscopic System, Obturator, Standard
Ethicon Inc.
01934
Not in Commercial Distribution

  • 10705031000933 ()
01934

  • Rigid endoscope obturator
Resectoscopic System, Working Element, Passive
Ethicon Inc.
01931
Not in Commercial Distribution

  • 10705031000926 ()
01931

  • Electrosurgical handpiece/electrode holder, reusable
Resectoscopic System, Bridge - Hysteroscopic (Obturator - Visual)
Ethicon Inc.
01735
Not in Commercial Distribution

  • 10705031000919 ()
01735

  • Rigid endoscope obturator
No Description
VISION RT LIMITED
SafeRT-ID (with interlock)
Not in Commercial Distribution

  • 05056190500382 ()


  • Patient-administration information system application software
Rotary Microtome - Accessory
SHANDON DIAGNOSTICS LIMITED
Cool-Cut with STD
In Commercial Distribution

  • 05051663517904 ()
771120

  • Rotary microtome IVD
Rotary Microtome - Accessory
SHANDON DIAGNOSTICS LIMITED
Cool-Cut with UCC
In Commercial Distribution

  • 05051663517898 ()
771110

  • Rotary microtome IVD
No Description
SHANDON DIAGNOSTICS LIMITED
NX70 CRYOSTAR WITH
In Commercial Distribution

  • 05051663010429 ()


  • Cryostat microtome IVD
No Description
SHANDON DIAGNOSTICS LIMITED
NX70 CRYOSTAR WITH
In Commercial Distribution

  • 05051663010382 ()


  • Cryostat microtome IVD
No Description
SHANDON DIAGNOSTICS LIMITED
NX70 CRYOSTAR WITH
In Commercial Distribution

  • 05051663010344 ()


  • Cryostat microtome IVD
Obstructive Sleep Apnea Device with twin mated posts and Patient Monitoring
PROSOMNUS SLEEP TECHNOLOGIES
MicrO2 with Monitoring
In Commercial Distribution

  • 00863039000447 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
zuvo 16 with eyespeak, speech generating device
Talk To ME Technologies, LLC
16 with eyespeak
In Commercial Distribution

  • 00850041729084 ()


  • Voice synthesizer/digitizer
zuvo 12 with eyespeak, speech generating device
Talk To ME Technologies, LLC
12 with eyespeak
In Commercial Distribution

  • 00850041729077 ()


  • Voice synthesizer/digitizer
The 50EW is a rechargeable pulse oximeter that is designed to accurately measure oxygen saturation (SpO2) and pulse rate through your finger.
LORTE TECHNOLOGIES, INC
CMS-50EW with Bluetooth
In Commercial Distribution

  • 00851908007062 ()


  • Pulse oximeter
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