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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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LuminScan(TM) Imaging System - 26932503570019

The machine model is C1, the light source sweep frequency is 100kHz
Micro-Tech (Nanjing) Co., Ltd.
EOCT-C1-10-10
In Commercial Distribution

  • 26932503570019 ()


  • Coronary optical coherence tomography system

alpHaONE - 06946332804173

pH capsule
Chongqing Jinshan Science & Technology (Group) Co., Ltd
JSPC-1
In Commercial Distribution

  • 16946332804170 ()
  • 06946332804173 ()


  • Gastrointestinal telemetric monitoring system capsule, ingestible

alpHaONE - 06946332800045

pH capsule, 1 pack
Chongqing Jinshan Science & Technology (Group) Co., Ltd
JSPC-1
In Commercial Distribution

  • 06946332800625 ()
  • 06946332800045 ()
  • 06946332800632 ()


  • Gastrointestinal telemetric monitoring system capsule, ingestible

Luminscan(TM) Disposable Imaging Kit - 06932503570022

The diameter of the balloon is 16mm, the effective length is 30mm, the outer diameter of the Balloon catheter is 7Fr, and the length of the probe is 2500mm
Micro-Tech (Nanjing) Co., Ltd.
BOP-16-30-25-7
In Commercial Distribution

  • 16932503570029 ()
  • 06932503570022 ()
  • 26932503570026 ()

  • Balloon Diameter: 16 Centimeter
  • Balloon Length: 30 Millimeter
  • Length: 250 Centimeter


  • Coronary optical coherence tomography system

ILUMIEN™ OPTIS™ to OPTIS™ - 05415067053879

Mobile Next Direct Upgrade Accessory Kit
LIGHTLAB IMAGING, INC.
UIMG901003
In Commercial Distribution

  • 05415067053879 ()
UIMG901003

  • Coronary optical coherence tomography system

CathCheck Disposable Kit - 00618874601133

CathCheck Disposable Kit box single pouch, which consists of 1 adaptor,1 pressure transducer to be used with CompuFlo Epidural Computer Controlled Anesthesia System
Milestone Scientific Inc.
EPI-6011-03
In Commercial Distribution

  • 00618874601133 ()


  • Epidural anaesthesia set, non-medicated

SkyWalker - 00850030914323

No Description
Microport Navibot International LLC
NB-10147
In Commercial Distribution

  • 00850030914323 ()
NB-10147

  • Imaging lesion localization marker, external, single-use

N/A - 00850030914255

Marker Box (40)
Microport Navibot International LLC
10035-NB
In Commercial Distribution

  • 00850030914255 ()
10035NB

  • Imaging lesion localization marker, external, single-use

RELI - 00386120008608

MAMMOREP N® Breast localization needle, simple hook-wire 21G x 15cm
MYCO MEDICAL SUPPLIES INC.
R-MRN2115
In Commercial Distribution

  • 10386120008605 ()
  • 00386120008608 ()

  • Length: 15 Centimeter
  • Needle Gauge: 21 Gauge
R-MRN2115

  • Imaging lesion localization marker, external, single-use

RELI - 00386120008592

MAMMOREP N® Breast localization needle, simple hook-wire 21G x 11cm
MYCO MEDICAL SUPPLIES INC.
R-MRN2111
In Commercial Distribution

  • 10386120008599 ()
  • 00386120008592 ()

  • Length: 11 Centimeter
  • Needle Gauge: 21 Gauge
R-MRN2111

  • Imaging lesion localization marker, external, single-use
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