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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
392-0306
In Commercial Distribution

  • 04540778176997 ()

  • Complex (Extra Soft) 10inch 3mm x 6cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
392-0306

  • 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
392-0304
In Commercial Distribution

  • 04540778176980 ()

  • Complex (Extra Soft) 10inch 3mm x 4cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
392-0304

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
Integra Peritoneal Open-Ended Catheter With Slits PERITONEAL CATHETER, 90CM LENGTH 12 mm H2O at a flow rate of 23 ml/hr.
Integra Lifesciences Corporation
NL98003S01
In Commercial Distribution

  • 10381780072546 ()
  • M269NL98003S011 ()

  • Tubing: 1.3mm ID x 2.5mm OD; Total Length: 90 cm (35 1/2") (All dimensions nominal)
NL98003S01

  • Peritoneal/atrial cerebrospinal fluid catheter
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
392-0408
In Commercial Distribution

  • 04540778177031 ()

  • Complex (Soft) 10inch 4mm x 8cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
392-0408

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
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
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
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
.050" Hex. Cylindrical stainless steel pins threaded at one end used for open tray impressions or as a pin to wax to when creating a crown.
STERNGOLD DENTAL LLC
904660
In Commercial Distribution

  • 00841549117435 ()


  • Dental prosthesis/implant abutment screw
.050" Hex. Cylindrical stainless steel pins threaded at one end used for open tray impressions or as a pin to wax to when creating a crown.
STERNGOLD DENTAL LLC
904659
In Commercial Distribution

  • 00841549117428 ()


  • Dental prosthesis/implant abutment screw
.050" Hex. Cylindrical stainless steel pins threaded at one end used for open tray impressions or as a pin to wax to when creating a crown.
STERNGOLD DENTAL LLC
904658
In Commercial Distribution

  • 00841549117411 ()


  • Dental prosthesis/implant abutment screw
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