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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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Fuel-Cell technology provides you with increased precision and accuracy, and also less worry with maintenance, since fuel-cell alcohol sensor modules are rated to at least 1000 tests before needing replacement. Fuel-Cell Sensor Modules should be replaced approximately every 1000 tests, or at least once yearly.
AK Globaltech Corp
SM200
In Commercial Distribution

  • 00853464001348 ()
AKG-SM200

  • Alcohol breath analyser
BPro® Ambulatory Blood Pressure Monitoring System is a noninvasive ambulatory blood pressure monitoring (ABPM) system based on arterial tonometry at the radial artery and oscillometry at the upper arm. It is used for measuring systolic pressure, diastolic pressure and pulse rate of adults.
HEALTHSTATS INTERNATIONAL PTE LTD
T6200 Series
Not in Commercial Distribution

  • 08885014410012 ()


  • Blood pressure ambulatory recorder
Terragene Bionova® SCBI(BT96) is a self-contained biological indicator inoculated with viable 10^6 Geobacillus sterotheromophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydorgen peroxide sterilization processes. BT96 has Super Rapid readout at 30 minutes at 60 degree celsius.
Plasmapp Co.,Ltd.
BT96
In Commercial Distribution

  • 08800066500184 ()


  • Biological sterilization indicator
Provent 30 Night Standard Pack contains 30 Standard resistance Provent
PROVENT SLEEP THERAPY, LLC
CAT1105
In Commercial Distribution

  • 00868020000208 ()

  • Expiratory Resistance 3.0 >= x < 8.0 cm H2O at 50 mL/sec flow rate per nostril
CAT1105

  • Nasal dilator
The transport shelf is an accessory. It's intended to be installed at foot end of the bed in the corner bumper.
Umano Medical Inc
299-0523WG-TRI
In Commercial Distribution

  • 00670482000722 ()
  • 10670482000729 ()


  • Basic electric hospital bed
SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 2X8, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111TX-16-066-NS
In Commercial Distribution

  • 00650551087410 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111TX-16-066-NS

  • Cortical electrode
SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111TX-16-062-NS
In Commercial Distribution

  • 00650551087335 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2111TX-16-062-NS

  • Cortical electrode
SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 2X8, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-16-066-NS
In Commercial Distribution

  • 00650551087403 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2111-16-066-NS

  • Cortical electrode
SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-16-062-NS
In Commercial Distribution

  • 00650551087328 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111-16-062-NS

  • Cortical electrode
The 2nd Generation Re-Inforced Semiconductor Sensor by AlcoMate. Replacement needed every 200 tests or at least once yearly, whichever comes first.
AK Globaltech Corp
SM7000
In Commercial Distribution

  • 00853464001119 ()
AKG SM7000

  • Alcohol breath analyser
SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 2X8, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111TX-16-066
In Commercial Distribution

  • 00650551062844 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111TX-16-066

  • Cortical electrode
SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 2X8, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-16-066
In Commercial Distribution

  • 00650551062837 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111-16-066

  • Cortical electrode
SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111TX-16-062
In Commercial Distribution

  • 00650551062769 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111TX-16-062

  • Cortical electrode
SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-16-062
In Commercial Distribution

  • 00650551062752 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2111-16-062

  • Cortical electrode
SUBDURAL STRIP ELECTRODE, PLATINUM, 8 CONTACT, 1X8, RADIOPAQUE "L" AT CONTACT #1 & #8, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2110-08-093-NS
In Commercial Distribution

  • 00650551074670 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.76 Millimeter
2110-08-093-NS

  • Cortical electrode
It is used when removing the gums at the location where the fixture will be installed during dental implant fixture surgery.
Shinhung MST Co., Ltd.
GTP35
In Commercial Distribution

  • 08806343924049 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Nagahara Ambidextrous Nucleus Chopper, Round Knurled Handle, 1.5mm Tip, Blade Set At 90 Degrees Angle, Overall Length 4 1/2" (11cm)
Med Saver, Inc.
15-3626AS
In Commercial Distribution

  • 00194613085179 ()


  • Ophthalmic knife, reusable
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
393-030530
In Commercial Distribution

  • 04540778190429 ()

  • Complex (Infini Silky Soft) 12inch 3-5mm x 30cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
393-030530

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
390-0212
In Commercial Distribution

  • 04540778190412 ()

  • Complex (Silky Soft) 10inch 2mm x 12cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-0212

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
374-142450
In Commercial Distribution

  • 04540778177796 ()

  • Helical (Infini Standard) 17inch 14-24mm x 50cm
  • Compatible Microcatheter inner diameter: 0.48 to 0.53 Millimeter
374-142450

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
373-122050
In Commercial Distribution

  • 04540778177772 ()

  • Helical (Infini Standard) 14inch 12-20mm x 50cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
373-122050

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
373-051250
In Commercial Distribution

  • 04540778177734 ()

  • Helical (Infini Soft) 14inch 5-12mm x 50cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
373-051250

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
373-051230
In Commercial Distribution

  • 04540778177710 ()

  • Helical (Infini Soft) 14inch 5-12mm x 30cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
373-051230

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
373-040830
In Commercial Distribution

  • 04540778177659 ()

  • Helical (Infini Extra Soft) 14inch 4-8mm x 30cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
373-040830

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
373-040815
In Commercial Distribution

  • 04540778177635 ()

  • Helical (Infini Extra Soft) 14inch 4-8mm x 15cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
373-040815

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
373-040810
In Commercial Distribution

  • 04540778177628 ()

  • Helical (Infini Extra Soft) 14inch 4-8mm x 10cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
373-040810

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
372-041030
In Commercial Distribution

  • 04540778177611 ()

  • Helical (Infini Soft) 10inch 4-10mm x 30cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
372-041030

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
372-041020
In Commercial Distribution

  • 04540778177604 ()

  • Helical (Infini Soft) 10inch 4-10mm x 20cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
372-041020

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
371-041015
In Commercial Distribution

  • 04540778177550 ()

  • Helical (Infini Extra Soft) 10inch 4-10mm x 15cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
371-041015

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
371-041010
In Commercial Distribution

  • 04540778177543 ()

  • Helical (Infini Extra Soft) 10inch 4-10mm x 10cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
371-041010

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
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