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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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Haefliger Phaco Cleaver, For use in Left hand, Angled 10mm from bend to tip, Round Knurled Handle, 115mm Overall Length, Stainless Steel
Crestpoint Management Limited
PH6363R
In Commercial Distribution

  • G412PH6363R0 ()


  • Soft-tissue surgical hook, reusable
Haefliger Phaco Cleaver, For use in RIGHT hand, Angled 10mm from bend to tip, Round Knurled Handle, 115mm Overall Length, Stainless Steel
Crestpoint Management Limited
PH6363L
In Commercial Distribution

  • G412PH6363L0 ()


  • Soft-tissue surgical hook, reusable
Noromed SEMG, with broader operating ranges, greater sensitivity, and unsurpassed ability to eliminate extraneous electrical "noise", provides an SEMG platform you can use with confidence. With Noromed SEMG you know you are getting true, reliable and repeatable results. In evaluating the technological sophistication, superiority and reliability of SEMG systems, the most important factors are sensitivity (usually expressed in microvolts), the monitoring range (again usually expressed in microvolts), and how the instrument eliminates ambient electrical noise.
MYOTRONICS NOROMED, INC
Static EMG Scanner
In Commercial Distribution

  • D792N150MES0 ()
  • D792N9150 ()


  • Patient monitoring system module, electromyographic
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)
CFSH
Not in Commercial Distribution

  • 10381780036814 ()
  • M272CFSH1 ()

  • High Pressure at 20ml/h: 12.7-18.0cmH2O
CFSH

  • Ventriculo-peritoneal/atrial shunt
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)
CFRM
Not in Commercial Distribution

  • 10381780036807 ()
  • M272CFRM1 ()

  • Medium Pressure at 20ml/h: 6.7-11.8cmH2O
CFRM

  • Ventriculo-peritoneal/atrial shunt
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)
CFRL
Not in Commercial Distribution

  • 10381780036791 ()
  • M272CFRL1 ()

  • Low Pressure at 20ml/h: 1.2-5.8cmH2O
CFRL

  • Ventriculo-peritoneal/atrial shunt
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)
CFRH
Not in Commercial Distribution

  • 10381780036784 ()
  • M272CFRH1 ()

  • High Pressure at 20ml/h: 12.7-18.0cmH2O
CFRH

  • Ventriculo-peritoneal/atrial shunt
The mini Kompressor Compression Screw is a two-piece fixation device intended for the use in the reduction, stabilization, and internal fixation of bone fractures. The 2-piece design incorporates the use of a leading and trailing screw component. The implant utilizes a variance in thread pitch between the leading and trailing portions of the screw to reduce and fix fracture fragments, and is available in a variety of sizes to accommodate various fracture types and sites.
Ascension Orthopedics, Inc.
210326
Not in Commercial Distribution

  • M2482103261 ()
  • 10381780065777 ()

  • 3.6 mm dia x 30 mm L; leading screw 26 mm L
210326

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The mini Kompressor Compression Screw is a two-piece fixation device intended for the use in the reduction, stabilization, and internal fixation of bone fractures. The 2-piece design incorporates the use of a leading and trailing screw component. The implant utilizes a variance in thread pitch between the leading and trailing portions of the screw to reduce and fix fracture fragments, and is available in a variety of sizes to accommodate various fracture types and sites.
Ascension Orthopedics, Inc.
210324
Not in Commercial Distribution

  • M2482103241 ()
  • 10381780065760 ()

  • 3.6 mm dia x 28 mm L; leading screw 24 mm L
210324

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The mini Kompressor Compression Screw is a two-piece fixation device intended for the use in the reduction, stabilization, and internal fixation of bone fractures. The 2-piece design incorporates the use of a leading and trailing screw component. The implant utilizes a variance in thread pitch between the leading and trailing portions of the screw to reduce and fix fracture fragments, and is available in a variety of sizes to accommodate various fracture types and sites.
Ascension Orthopedics, Inc.
210322
Not in Commercial Distribution

  • M2482103221 ()
  • 10381780065753 ()

  • 3.6 mm dia x 26 mm L; leading screw 26 mm L
210322

  • Orthopaedic bone screw, non-bioabsorbable, sterile
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