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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 interlocking intramedullary nail is intended for use in fixation of various types of fractures, including diaphyseal fractures and short distal or proximal fragments in the long bones. Includes nail cap.
CARBOFIX ORTHOPEDICS LTD
Interlocking Tibial Nail
Not in Commercial Distribution

  • 07290109330907 ()

  • Length: 280 Millimeter
  • Insertion Diameter: 8.5 Millimeter
  • Expanded Diameter: 13.5 Millimeter
  • Proximal Diameter: 10.5 Millimeter
2213528

  • Tibia intramedullary nail
The interlocking intramedullary nail is intended for use in fixation of various types of fractures, including diaphyseal fractures and short distal or proximal fragments in the long bones. Includes nail cap.
CARBOFIX ORTHOPEDICS LTD
Interlocking Tibial Nail
Not in Commercial Distribution

  • 07290109330891 ()

  • Proximal Diameter: 10.5 Millimeter
  • Expanded Diameter: 13.5 Millimeter
  • Insertion Diameter: 8.5 Millimeter
  • Length: 260 Millimeter
2213526

  • Tibia intramedullary nail
A plate indicated for fusion and arthrodesis of the 1st tarsometatarsal joint (Lapidus Fusions)
CARBOFIX ORTHOPEDICS LTD
Lapidus Plate
In Commercial Distribution

  • 07290110205072 ()

  • Plantar Step: 2 mm
  • Length: 36 Millimeter
LAP100002

  • Orthopaedic fixation plate, non-bioabsorbable
A plate indicated for fusion and arthrodesis of the 1st tarsometatarsal joint (Lapidus Fusions)
CARBOFIX ORTHOPEDICS LTD
Lapidus Plate
In Commercial Distribution

  • 07290110205065 ()

  • Length: 36 Millimeter
  • Plantar Step: 1 mm
LAP100001

  • Orthopaedic fixation plate, non-bioabsorbable
A plate indicated for fusion and arthrodesis of the 1st tarsometatarsal joint (Lapidus Fusions)
CARBOFIX ORTHOPEDICS LTD
Lapidus Plate
In Commercial Distribution

  • 07290110205058 ()

  • Plantar Step: 0
  • Length: 36 Millimeter
LAP100000

  • Orthopaedic fixation plate, non-bioabsorbable
Fracture Reduction System. Fracture reduction and external fixation for treatment of distal radius fractures.
Hand Biomechanics Lab Inc
CFD-147
In Commercial Distribution

  • 00861994000205 ()


  • Orthopaedic bone pin, non-bioabsorbable
This product is comprised of a stainless steel core wire with distal platinum tungsten coil and proximal stainless steel coil, and includes a shaping mandrel and a torque device. The guidewire distal tip is straight and shapeable. The diameters of the guidewires are listed in the table below. The guidewires are compatible with devices with inner diameters (IDs) specified in the table below. The distal 30 mm of the guidewire tip is radiopaque. Confirm the compatibility of the guidewire diameter with the interventional device before use. For lubricity, the distal 300 mm of the device is coated with hydrophilic coating and the proximal portion of the guidewire is coated with hydrophobic polytetrafluoroethylene (PTFE).The shaping mandrel included with the guidewire can be used to shape the tip of the guidewire as appropriate. When shaping the tip, carefully crimp it while the surface is wet. The torque device included with the guidewire attaches to the proximal end of the wire and functions as a steering guide. Rotation of the torque device facilitates guidewire placement into the target vessel by manipulation of the guidewire tip.
Enlight Medical Technologies(Shenzhen) Co., Ltd.
GW1410
In Commercial Distribution

  • 06945258302022 ()


  • Neurovascular embolization coil
This product is comprised of a stainless steel core wire with distal platinum tungsten coil and proximal stainless steel coil, and includes a shaping mandrel and a torque device. The guidewire distal tip is straight and shapeable. The diameters of the guidewires are listed in the table below. The guidewires are compatible with devices with inner diameters (IDs) specified in the table below. The distal 30 mm of the guidewire tip is radiopaque. Confirm the compatibility of the guidewire diameter with the interventional device before use. For lubricity, the distal 300 mm of the device is coated with hydrophilic coating and the proximal portion of the guidewire is coated with hydrophobic polytetrafluoroethylene (PTFE).The shaping mandrel included with the guidewire can be used to shape the tip of the guidewire as appropriate. When shaping the tip, carefully crimp it while the surface is wet. The torque device included with the guidewire attaches to the proximal end of the wire and functions as a steering guide. Rotation of the torque device facilitates guidewire placement into the target vessel by manipulation of the guidewire tip.
Enlight Medical Technologies(Shenzhen) Co., Ltd.
GW1010
In Commercial Distribution

  • 06945258302015 ()


  • Neurovascular embolization coil
Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone Particles Indications for Use: Oral and maxillofacial surgery and dentistry • Augmentation or reconstructive treatment of the alveolar ridge • Filling of infrabony periodontal defects • Filling of defects after root resection, apicoectomy, and cystectomy • Filing of extraction sockets to enhance preservation of the alveolar ridge • Elevation of the maxillary sinus floor
curasan AG
1-2mm
In Commercial Distribution

  • 04260476431128 ()
1x2cc

  • Dental bone matrix implant, synthetic
Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone Particles Indications for Use: Oral and maxillofacial surgery and dentistry • Augmentation or reconstructive treatment of the alveolar ridge • Filling of infrabony periodontal defects • Filling of defects after root resection, apicoectomy, and cystectomy • Filing of extraction sockets to enhance preservation of the alveolar ridge • Elevation of the maxillary sinus floor
curasan AG
1-2mm
In Commercial Distribution

  • 04260476431111 ()
1x1cc

  • Dental bone matrix implant, synthetic
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