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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 i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-1450
In Commercial Distribution

  • 04540778177239 ()

  • Complex (Standard) 14inch 14mm x 50cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
392-1450

  • 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
392-1250
In Commercial Distribution

  • 04540778177222 ()

  • Complex (Medium Soft) 14inch 12mm x 50cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
392-1250

  • 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
392-1040
In Commercial Distribution

  • 04540778177208 ()

  • Complex (Medium Soft) 14inch 10mm x 40cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
392-1040

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The Gravity Compensating Accessory (GCA) is designed to counterbalance gravity’s effects on the fluid column within the drainage catheter of an implanted shunt system. The GCA consists of a silicone elastomer encased stainless steel housing with a ruby ball held in a stainless steel seat (in the vertical orientation) by two to four stainless steel balls. In the horizontal orientation, a minimal resistance to flow (<30mmH2O at 5ml/h) is added to the system, and in the vertical orientation: 140-170, 200-250 or 260-320mmH2O (at 5ml/h).
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
903440
Not in Commercial Distribution

  • 10381780033530 ()
  • M2729034401 ()

  • High Pressure Range, Additional Resistance to Flow at 5ml/h, Horizontal Orientation < 30mmH2O, Vertical Orientation: 260-320mmH2O
903440

  • Ventriculo-peritoneal/atrial shunt
Gravity Compensating Accessory, High Pressure Range (Brown)
NATUS MEDICAL INCORPORATED
NT903440
In Commercial Distribution


  • High Pressure Range, Additional Resistance to Flow at 5ml/h, Horizontal Orientation < 30mmH2O, Vertical Orientation: 260-320mmH2O
NT903440

  • Ventriculo-peritoneal/atrial shunt
9.5F PLASTIC DIGNITY®DUAL CT PORT W/ATTACHABLECT PORT W/AT CHRONOFLEX®POLYURETHANE CATHETER W/5F MICRO-STICK® INTRODUCER SETINTRODUCER SET
Medical Components, Inc.
MICTI95002
Not in Commercial Distribution

  • 50884908103637 ()
  • 00884908103632 ()
MICTI95002

  • Vascular port/catheter
S-ROM LINER LOCKING PIN 5.0mm
DEPUY ORTHOPAEDICS, INC.
55-0295
In Commercial Distribution

  • 10603295175162 ()
550295

  • Implantable orthopaedic/craniofacial device connection screw
S-ROM LINER LOCKING PIN 3.5mm
DEPUY ORTHOPAEDICS, INC.
55-0235
In Commercial Distribution

  • 10603295175155 ()
550235

  • Implantable orthopaedic/craniofacial device connection screw
S-ROM TROCHANTER SCREW 62mm
DEPUY ORTHOPAEDICS, INC.
53-8162
In Commercial Distribution

  • 10603295173496 ()
538162

  • Implantable orthopaedic/craniofacial device connection screw
S-ROM TROCHANTER SCREW 52mm
DEPUY ORTHOPAEDICS, INC.
53-8152
In Commercial Distribution

  • 10603295173489 ()
538152

  • Implantable orthopaedic/craniofacial device connection screw
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