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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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Contour-Flex Valve and Shunt System - 10381780032861

The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral connectors. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the brain. The Contour-Flex Valve design includes a flat silicone membrane, which provides resistance to CSF flow. The Contour-Flex Valve is available in two sizes: Regular and Small. Both sizes are available in 3 pressure/flow characteristics ranges: low, medium, and high.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
11854
Not in Commercial Distribution

  • 10381780032861 ()
  • M272118541 ()

  • Low Pressure at 20ml/h: 1.2-5.8cmH2O, Outlet Tubing 91cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Vent. Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8)
11854

  • Ventriculo-peritoneal/atrial shunt

Infinity-Lock Button System - 05060267131836

No Description
XIROS LTD
102-1089
In Commercial Distribution

  • 05060267131836 ()
n/a

  • Acromioclavicular joint stabilization implant
  • Cannulated surgical drill bit, single-use

NILE™ Alternative Fixation System - 10888857269101

Clamp Assembly Size Ø5.5 mm MESA Rail™
K2M, INC.
5401-85500H-G2
In Commercial Distribution

  • 10888857269101 ()

  • Outer Diameter: 5.5 Millimeter
5401-85500H-G2

  • Internal spinal fixation system cable

NILE™ Alternative Fixation System - 10888857269095

Clamp Assembly Size Ø5.5 mm
K2M, INC.
5401-85500-G2
In Commercial Distribution

  • 10888857269095 ()

  • Outer Diameter: 5.5 Millimeter
5401-85500-G2

  • Internal spinal fixation system cable

NILE™ Alternative Fixation System - 10888857269088

Clamp Assembly Size Ø4.5 mm Rail / Ø6.0 mm
K2M, INC.
5401-84500H-G2
In Commercial Distribution

  • 10888857269088 ()

  • Outer Diameter: 4.5 Millimeter
  • Outer Diameter: 6 Millimeter
5401-84500H-G2

  • Internal spinal fixation system cable

NILE™ Alternative Fixation System - 10888857269071

Clamp Assembly Size Ø4.5 mm
K2M, INC.
5401-84500-G2
In Commercial Distribution

  • 10888857269071 ()

  • Outer Diameter: 4.5 Millimeter
5401-84500-G2

  • Internal spinal fixation system cable

STERNAL CABLE SYSTEM - 00846468053727

SS BLUNT NEEDLE, 64mm, 4 CABLES PER POUCH
Pioneer Surgical Technology, Inc.
402-618-64
Not in Commercial Distribution

  • 00846468053727 ()
402-618-64

  • Internal spinal fixation system cable

SONGER® SPINAL CABLE SYSTEM - 00846468061913

CUTTER, CABLE, SPINAL
Pioneer Surgical Technology, Inc.
686.304
Not in Commercial Distribution

  • 00846468061913 ()


  • Internal spinal fixation system cable

SONGER® SPINAL CABLE SYSTEM - 00846468061906

Nerve Hook, Spinal
Pioneer Surgical Technology, Inc.
686.303
Not in Commercial Distribution

  • 00846468061906 ()


  • Internal spinal fixation system cable

SONGER® SPINAL CABLE SYSTEM - 00846468061890

Nerve Hook, Spinal
Pioneer Surgical Technology, Inc.
686.303
Not in Commercial Distribution

  • 00846468061890 ()


  • Internal spinal fixation system cable
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