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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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8F PLASTIC Pro-Fuse® CT PORT W/ATTACHABLECT PORT W/AT ChronoFlex®POLYURETHANE CATHETERCATHETER
Medical Components, Inc.
MRCTT80001OR
Not in Commercial Distribution

  • 50884908149000 ()
  • 00884908149005 ()
MRCTT80001OR

  • Vascular port/catheter
OptiFix AT Absorbable Fixation System with Articulating Technology, 37 cm length, 5 mm diameter, 30 Fasteners
Davol Inc.
0113330
In Commercial Distribution

  • 10801741136563 ()
  • 00801741136566 ()

  • Length: 37 Centimeter
  • Outer Diameter: 5 Millimeter
0113330

  • Soft-tissue/mesh anchor, bioabsorbable
OptiFix AT Absorbable Fixation System with Articulating Technology, 37 cm length, 5 mm diameter, 15 Fasteners
Davol Inc.
0113315
In Commercial Distribution

  • 10801741136556 ()
  • 00801741136559 ()

  • Length: 37 Centimeter
  • Outer Diameter: 5 Millimeter
0113315

  • Soft-tissue/mesh anchor, bioabsorbable
Gravity Compensating Accessory, Low Pressure Range (White)
NATUS MEDICAL INCORPORATED
NT903430
In Commercial Distribution


  • Additional Resistance to Flow at 5ml/h, Horizontal Orientation < 30mmH2O, Vertical Orientation: 140-170mmH2O
NT903430

  • Ventriculo-peritoneal/atrial shunt
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
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
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
The sterile, single use Flo-Thru Intraluminal Shunt is a one-piece radiopaque silicone tube with atraumatic bulbs shaped at each end. Openings at the ends of the bulbs allow blood to flow through the shunt and distal to the anastomosis.
SYNOVIS LIFE TECHNOLOGIES, INC.
FT-12300
In Commercial Distribution

  • 50085412532511 ()
  • 00085412532516 ()
FT12300

  • Surgical intravascular shunt
The sterile, single use Flo-Thru Intraluminal Shunt is a one-piece radiopaque silicone tube with atraumatic bulbs shaped at each end. Openings at the ends of the bulbs allow blood to flow through the shunt and distal to the anastomosis.
SYNOVIS LIFE TECHNOLOGIES, INC.
FT-12275
In Commercial Distribution

  • 50085412532504 ()
  • 00085412532509 ()
FT12275

  • Surgical intravascular shunt
The sterile, single use Flo-Thru Intraluminal Shunt is a one-piece radiopaque silicone tube with atraumatic bulbs shaped at each end. Openings at the ends of the bulbs allow blood to flow through the shunt and distal to the anastomosis.
SYNOVIS LIFE TECHNOLOGIES, INC.
FT-12250
In Commercial Distribution

  • 50085412532498 ()
  • 00085412532493 ()
FT12250

  • Surgical intravascular shunt
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