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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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Pennig Minifixator - 18033509851919

PMF THREADED WIRES D 1.6 MM STERILE LENGTH 70/15 MM (PACK OF 4)
ORTHOFIX SRL
1
In Commercial Distribution

  • 18033509851919 ()

  • Outer Diameter: 1.6 Millimeter
  • THREAD LENGHT 15 MM
  • Length: 70 Millimeter
99-M420

  • Orthopaedic bone wire

Piccolo Composite Plate System - 07290110205072

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

Piccolo Composite Plate System - 07290110205065

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

Piccolo Composite Plate System - 07290110205058

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

Agee WristJack® - 00861994000205

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

Synxess - 06945258302022

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

Synxess - 06945258302015

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

B.BRAUN - 04046964310881

6F PICC TRIPLE 60 NITGLD130 CTT660-NG130
B BRAUN INTERVENTIONAL SYSTEMS, INC
613412
Not in Commercial Distribution

  • 04046964310881 ()
  • 04046964310874 ()

  • Length of guidewire : 130.000 CM
  • Length of catheter : 60.000 CM
  • Catheter Gauge: 6.00 French
613412

  • Peripherally-inserted central venous catheter

B.BRAUN - 04046964310850

6F PICC TRIPLE 60 NITGOLD 80 CTT660-NG80
B BRAUN INTERVENTIONAL SYSTEMS, INC
613411
Not in Commercial Distribution

  • 04046964310850 ()
  • 04046964310836 ()

  • Length of guidewire : 80.000 CM
  • Length of catheter : 60.000 CM
  • Catheter Gauge: 6.00 French
613411

  • Peripherally-inserted central venous catheter

B.BRAUN - 04046964310812

6F PICC DUAL 60 NITGLD130 CTD660-NG130
B BRAUN INTERVENTIONAL SYSTEMS, INC
613408
Not in Commercial Distribution

  • 04046964310812 ()
  • 04046964310782 ()

  • Length of catheter : 60.000 CM
  • Catheter Gauge: 6.00 French
  • Length of guidewire : 130.000 CM
613408

  • Peripherally-inserted central venous catheter
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