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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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Natus® - 00382830055437

Gravity Compensating Accessory, Medium Pressure Range (Yellow)
NATUS MEDICAL INCORPORATED
NT903435
In Commercial Distribution


  • Additional Resistance to Flow at 5ml/h, Horizontal Orientation < 30mmH2O, Vertical Orientation: 200-250mmH2O
NT903435

  • Ventriculo-peritoneal/atrial shunt

Gravity Compensating Accessory - 10381780033516

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)
903430
Not in Commercial Distribution

  • 10381780033516 ()
  • M2729034301 ()

  • Additional Resistance to Flow at 5ml/h, Horizontal Orientation < 30mmH2O, Vertical Orientation: 140-170mmH2O
903430

  • Ventriculo-peritoneal/atrial shunt

Gravity Compensating Accessory - 10381780033523

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)
903435
Not in Commercial Distribution

  • 10381780033523 ()
  • M2729034351 ()

  • Additional Resistance to Flow at 5ml/h, Horizontal Orientation < 30mmH2O, Vertical Orientation: 200-250mmH2O
903435

  • Ventriculo-peritoneal/atrial shunt

PRO-FUSE® - 00884908148923

9.6F PLASTIC Pro-Fuse® CT PORT W/ATTACHABLECT PORT W/AT SILICONE CATHETER W/5FSILICONE C Micro-Stick®INTRODUCER SE
Medical Components, Inc.
MIPP96AFS
Not in Commercial Distribution

  • 50884908148928 ()
  • 00884908148923 ()
MIPP96AFS

  • Vascular port/catheter

i-ED COIL - 04540778176591

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
390-0308
In Commercial Distribution

  • 04540778176591 ()

  • Complex (Silky Soft) 10inch 3mm x 8cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-0308

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778176584

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
390-0306
In Commercial Distribution

  • 04540778176584 ()

  • Complex (Silky Soft) 10inch 3mm x 6cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-0306

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778176577

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
390-0304
In Commercial Distribution

  • 04540778176577 ()

  • Complex (Silky Soft) 10inch 3mm x 4cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-0304

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778176553

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
390-02H6
In Commercial Distribution

  • 04540778176553 ()

  • Complex (Silky Soft) 10inch 2.5mm x 6cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-02H6

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778176546

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
390-02H4
In Commercial Distribution

  • 04540778176546 ()

  • Complex (Silky Soft) 10inch 2.5mm x 4cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-02H4

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778176539

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
390-0208
In Commercial Distribution

  • 04540778176539 ()

  • Complex (Silky Soft) 10inch 2mm x 8cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-0208

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
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