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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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OLM INTRACRANIAL PRESSURE MONITORING KIT
INTEGRA LIFESCIENCES CORPORATION
110-4B
Not in Commercial Distribution

  • 10381780023623 ()
  • M2711104B04 ()

  • 0.106 in. (2.71 mm) diameter number 36 Drill Bit with safety stop; 0.050 in. (1.3 mm) diameter Stylet; 4 Fr (1.35 mm diameter) transducer tipped catheter
110-4B

  • Intracerebral sensor catheter, short-term
INTRACRANIAL PRESSURE-TEMPERATURE MONITORING KIT
NATUS MEDICAL INCORPORATED
110-4BT
In Commercial Distribution


  • 0.106 in. (2.71 mm) diameter number 36 Drill Bit with safety stop; 0.050 in. (1.3 mm) diameter Stylet; 4 Fr (1.35 mm diameter) transducer tipped catheter
1104BT

  • Intracerebral sensor catheter, short-term
OLM INTRACRANIAL PRESSURE MONITORING KIT
NATUS MEDICAL INCORPORATED
110-4B
In Commercial Distribution


  • 0.106 in. (2.71 mm) diameter number 36 Drill Bit with safety stop; 0.050 in. (1.3 mm) diameter Stylet; 4 Fr (1.35 mm diameter) transducer tipped catheter
1104B

  • Intracerebral sensor catheter, short-term
SWAN-GANZ TRUE SIZE THERMODULTION CATHETER, 5F
Edwards Lifesciences LLC
TS105F5
In Commercial Distribution

  • 00690103018295 ()

  • EXTERIOR DIAMETER: 5F (1.67MM), USABLE LENGTH: 100 CM, RECOMMENDED GUIDEWIRE SIZE-DISTAL LUMEN: 0.018 IN, RECOMMENDED GUIDEWIRE SIZE-INJECTATE LUMEN: 0.020 IN, MINIMUM INTRODUCER SIZE: 5F (1.67 MM)
TS105F5

  • Pulmonary artery balloon catheter, electrical
The TrapIt Trapping Balloon Catheters have an integrated shaft system and a balloon near the distal tip. The shaft has a lumen which is used for inflation of the balloon with contrast medium. As aid in positioning the balloon in a guide catheter a tactile feedback stop is integrated in the shaft. The shaft of the 100 cm compatible TrapIt has a shaft depth marking that aid in gauging balloon catheter position relative to the guiding catheter tip when used in 90 cm guide catheters.
IMDS Operations B.V.
TRP10015
In Commercial Distribution

  • 08718481740279 ()
TRP10015

  • Coronary angioplasty balloon catheter, basic
The TrapIt Trapping Balloon Catheters have an integrated shaft system and a balloon near the distal tip. The shaft has a lumen which is used for inflation of the balloon with contrast medium. As aid in positioning the balloon in a guide catheter a tactile feedback stop is integrated in the shaft. The shaft of the 100 cm compatible TrapIt has a shaft depth marking that aid in gauging balloon catheter position relative to the guiding catheter tip when used in 90 cm guide catheters.
IMDS Operations B.V.
TRP9015
In Commercial Distribution

  • 08718481740262 ()
TRP9015

  • Coronary angioplasty balloon catheter, basic
HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking. The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in two injections given at weekly intervals. The product is packaged in a one syringe pack.
FIDIA FARMACEUTICI SPA
89122-0496-01
In Commercial Distribution

  • M713891220496010 ()

  • Total Volume: 3 Milliliter
89122-0496-01

  • Synovial fluid supplementation medium
Distal Access torque devices are used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. Distal Access torque devices are not intended for use in the neurovasculature
ZIEN MEDICAL TECHNOLOGIES, INC.
SPN-1005
In Commercial Distribution

  • B090SPN10051 ()
  • B090SPN10050 ()
  • B090SPN10052 ()
SPN-1005

  • Torque manipulation device
Distal Access torque devices are used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. Distal Access torque devices are not intended for use in the neurovasculature
ZIEN MEDICAL TECHNOLOGIES, INC.
5X-GW
In Commercial Distribution

  • B0905XGW1 ()
  • B0905XGW0 ()
  • B0905XGW2 ()
5X-GW

  • Torque manipulation device
Featuring a traditional “spring” style handle that comes in blister packs of 10 needles and one guide tube, the Balance 1KS is an achievement in combining the highest quality with unprecedented value.
BLUE POPPY ENTERPRISES INC.
Balance 1KS-Type 2540
In Commercial Distribution

  • 10854166000742 ()
  • 30854166000746 ()

  • Outer Diameter: 0.25 Millimeter
  • Length: 40 Millimeter


  • Acupuncture needle, single-use
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