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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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The Sentosa SA201 Real-Time PCR Instrument is a real-time nucleic acid amplification and detection system. It measures nucleic acid signals from reverse transcribed RNA and converts the signals to comparative quantitative readouts using fluorescent detection of dual-labeled hydrolysis probes.
VELA OPERATIONS SINGAPORE PTE. LTD.
400125
In Commercial Distribution

  • 08885013950021 ()
400125

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
MERIFLUOR VZV is an in vitro direct immunofluorescent detection procedure for the detection of varicella-zoster virus (VZV) in vesicle smears and biopsy specimens. in addition, the reagent can be used to confirm the presence of VZV in cell culture.
MERIDIAN BIOSCIENCE, INC.
500113
In Commercial Distribution

  • 00840733101212 ()
500113

  • Varicella-zoster virus (VZV) antigen IVD, kit, direct fluorescent test (DFT)
The Intelesens Aingeal is used to monitor and transmit physiological data to a remote application for display or analysis by a clinician. The device can be worn by ambulatory or non-ambulatory adult patients in a healthcare environment to support clinical staff when they are carrying out their routine observations or when a patient would otherwise be in an unmonitored or unobserved situation. This re-usable device is intend to be used on the patient for short term periods only. The device is intended to be used on adult patients for monitoring of ECG, respiration, heart rate, skin temperature and activity levels in a healthcare setting. The device can be used where information on ECG, respiration, heart rate, skin temperature, and activity levels would be useful. The device uses on-board ECG arrhythmia detection algorithms to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event. The device transmits the data to the remote application at user defined intervals or upon the detection of an arrhythmia event (arrhythmia or threshold breach).
INTELESENS LIMITED
PN1111
In Commercial Distribution

  • 05060484630020 ()
  • 15060484630027 ()


  • Electrocardiography telemetric monitoring system
Melanoma Marker (HMB45) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human HMB45 antigen in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0625
In Commercial Distribution

  • 05055331322524 ()
PA0625

  • Melanoma specific protein IVD, antibody
Melanoma Marker (HMB45) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human HMB45 antigen in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0027
In Commercial Distribution

  • 05055331319104 ()
PA0027

  • Melanoma specific protein IVD, antibody
A PTFE coated metal wire with a flexible tip designed to position a catheter or similar interventional device (e.g., a stent or dilator) within an endoscope lumen into the gastrointestinal (GI) tract or the tracheobronchial tree. This is a single-use device
HOBBS MEDICAL, INC.
3412
In Commercial Distribution

  • M84934120 ()
3412

  • General-purpose non-vascular guidewire
A PTFE coated metal wire with a flexible tip designed to position a catheter or similar interventional device (e.g., a stent or dilator) within an endoscope lumen into the gastrointestinal (GI) tract or the tracheobronchial tree. This is a single-use device
HOBBS MEDICAL, INC.
3410
In Commercial Distribution

  • M84934100 ()
3410

  • General-purpose non-vascular guidewire
A PTFE coated metal wire with a flexible tip designed to position a catheter or similar interventional device (e.g., a stent or dilator) within an endoscope lumen into the gastrointestinal (GI) tract or the tracheobronchial tree. This is a single-use device
HOBBS MEDICAL, INC.
3406
In Commercial Distribution

  • M84934060 ()
3406

  • General-purpose non-vascular guidewire
The GALAXY MIS Screw System is intended to provide immobilization and Stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
BM KOREA CO., LTD
GC300-5510
In Commercial Distribution

  • 08809255540536 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 100 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
The GALAXY MIS Screw System is intended to provide immobilization and Stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
BM KOREA CO., LTD
GC300-5595
In Commercial Distribution

  • 08809255540529 ()

  • Length: 95 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
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