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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 CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. The device is manufactured from Stainless Steel.
Curvafix Inc
9.5 MM x 180 MM, Self Tapping
In Commercial Distribution

  • 10855068008072 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 180 Millimeter
CRS-095-180-02

  • Arthrodesis intramedullary nail, non-distracting
  • Orthopaedic bone screw, non-bioabsorbable, sterile
The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. The device is manufactured from Stainless Steel.
Curvafix Inc
9.5 MM x 170 MM, Self Tapping
In Commercial Distribution

  • 10855068008065 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 170 Millimeter
CRS-095-170-02

  • Arthrodesis intramedullary nail, non-distracting
  • Orthopaedic bone screw, non-bioabsorbable, sterile
The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. The device is manufactured from Stainless Steel.
Curvafix Inc
9.5 MM x 160 MM, Self Tapping
In Commercial Distribution

  • 10855068008058 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 160 Millimeter
CRS-095-160-02

  • Arthrodesis intramedullary nail, non-distracting
  • Orthopaedic bone screw, non-bioabsorbable, sterile
The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. The device is manufactured from Stainless Steel.
Curvafix Inc
9.5 MM x 150 MM, Self Tapping
In Commercial Distribution

  • 10855068008041 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 150 Millimeter
CRS-095-150-02

  • Arthrodesis intramedullary nail, non-distracting
  • Orthopaedic bone screw, non-bioabsorbable, sterile
The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. The device is manufactured from Stainless Steel.
Curvafix Inc
9.5 MM x 140 MM, Self Tapping
In Commercial Distribution

  • 10855068008034 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 140 Millimeter
CRS-095-140-02

  • Arthrodesis intramedullary nail, non-distracting
  • Orthopaedic bone screw, non-bioabsorbable, sterile
The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. The device is manufactured from Stainless Steel.
Curvafix Inc
9.5 MM x 130 MM, Self Tapping
In Commercial Distribution

  • 10855068008027 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 130 Millimeter
CRS-095-130-02

  • Arthrodesis intramedullary nail, non-distracting
  • Orthopaedic bone screw, non-bioabsorbable, sterile
The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. The device is manufactured from Stainless Steel.
Curvafix Inc
9.5 MM x 120 MM, Self Tapping
In Commercial Distribution

  • 10855068008010 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 120 Millimeter
CRS-095-120-02

  • Arthrodesis intramedullary nail, non-distracting
  • Orthopaedic bone screw, non-bioabsorbable, sterile
The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. The device is manufactured from Stainless Steel.
Curvafix Inc
9.5 MM x 110 MM, Self Tapping
In Commercial Distribution

  • 10855068008003 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 110 Millimeter
CRS-095-110-02

  • Arthrodesis intramedullary nail, non-distracting
  • Orthopaedic bone screw, non-bioabsorbable, sterile
The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.
Tem Innovations GmbH
delta System (US/CA)
In Commercial Distribution

  • 04260160470587 ()
201001

  • Coagulation analyser IVD, laboratory, semi-automated
The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.
Tem Innovations GmbH
delta System
In Commercial Distribution

  • 04260160470020 ()
200100-US

  • Coagulation analyser IVD, laboratory, semi-automated
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