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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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Supercath 5 - 04543527237215

No Description
TOGO MEDIKIT CO.,LTD.
SP125-24-19T
In Commercial Distribution

  • 14543527237212 ()
  • 04543527237215 ()
  • 84543527237211 ()


  • Peripheral intravenous cannula

Supercath 5 - 04543527235389

No Description
TOGO MEDIKIT CO.,LTD.
SP209-01
Not in Commercial Distribution

  • 74543527235388 ()
  • 14543527235386 ()
  • 04543527235389 ()

  • 0.7mm Catheter Diameter
  • 19 mm Catheter Length


  • Peripheral vascular catheter

Supercath 5 - 04543527235372

No Description
TOGO MEDIKIT CO.,LTD.
SP201-01
Not in Commercial Distribution

  • 74543527235371 ()
  • 14543527235379 ()
  • 04543527235372 ()

  • 25 mm Catheter Length
  • 0.9mm Catheter Diameter


  • Peripheral vascular catheter

Supercath 5 - 04543527235365

No Description
TOGO MEDIKIT CO.,LTD.
SP203-01
Not in Commercial Distribution

  • 14543527235362 ()
  • 04543527235365 ()
  • 74543527235364 ()

  • 0.9mm Catheter Diameter
  • 31 mm Catheter Length


  • Peripheral vascular catheter

Supercath 5 - 04543527235358

No Description
TOGO MEDIKIT CO.,LTD.
SP207-01
Not in Commercial Distribution

  • 74543527235357 ()
  • 14543527235355 ()
  • 04543527235358 ()

  • 1.1mm Catheter Diameter
  • 31 mm Catheter Length


  • Peripheral vascular catheter

Supercath 5 - 04543527235341

No Description
TOGO MEDIKIT CO.,LTD.
SP205-01
Not in Commercial Distribution

  • 14543527235348 ()
  • 04543527235341 ()
  • 74543527235340 ()

  • 31 mm Catheter Length
  • 1.3mm Catheter Diameter


  • Peripheral vascular catheter

Supercath 5 - 04543527235334

No Description
TOGO MEDIKIT CO.,LTD.
SP211-01
Not in Commercial Distribution

  • 74543527235333 ()
  • 14543527235331 ()
  • 04543527235334 ()

  • 31 mm Catheter Length
  • 1.7mm Catheter Diameter


  • Peripheral vascular catheter

Supercath 5 - 04543527235327

No Description
TOGO MEDIKIT CO.,LTD.
SP213-01
Not in Commercial Distribution

  • 74543527235326 ()
  • 14543527235324 ()
  • 04543527235327 ()

  • 31 mm Catheter Length
  • 2.1mm Catheter Diameter


  • Peripheral vascular catheter

Supercath 5 - 04543527235310

No Description
TOGO MEDIKIT CO.,LTD.
SP208-01
Not in Commercial Distribution

  • 14543527235317 ()
  • 04543527235310 ()
  • 74543527235319 ()

  • 0.7mm Catheter Diameter
  • 19 mm Catheter Length


  • Peripheral vascular catheter

Supercath 5 - 04543527235303

No Description
TOGO MEDIKIT CO.,LTD.
SP200-01
Not in Commercial Distribution

  • 14543527235300 ()
  • 04543527235303 ()
  • 74543527235302 ()

  • 25 mm Catheter Length
  • 0.9mm Catheter Diameter


  • Peripheral vascular catheter

Supercath 5 - 04543527235297

No Description
TOGO MEDIKIT CO.,LTD.
SP202-01
Not in Commercial Distribution

  • 74543527235296 ()
  • 14543527235294 ()
  • 04543527235297 ()

  • 31 mm Catheter Length
  • 0.9mm Catheter Diameter


  • Peripheral vascular catheter

Supercath 5 - 04543527235280

No Description
TOGO MEDIKIT CO.,LTD.
SP206-01
Not in Commercial Distribution

  • 74543527235289 ()
  • 14543527235287 ()
  • 04543527235280 ()

  • 31 mm Catheter Length
  • 1.1mm Catheter Diameter


  • Peripheral vascular catheter

Supercath 5 - 04543527235273

No Description
TOGO MEDIKIT CO.,LTD.
SP204-01
Not in Commercial Distribution

  • 14543527235270 ()
  • 04543527235273 ()
  • 74543527235272 ()

  • 1.3mm Catheter Diameter
  • 31 mm Catheter Length


  • Peripheral vascular catheter

Supercath 5 - 04543527235266

No Description
TOGO MEDIKIT CO.,LTD.
SP210-01
Not in Commercial Distribution

  • 74543527235265 ()
  • 14543527235263 ()
  • 04543527235266 ()

  • 31 mm Catheter Length
  • 1.7mm Catheter Diameter


  • Peripheral vascular catheter

Supercath 5 - 04543527235259

No Description
TOGO MEDIKIT CO.,LTD.
SP212-01
Not in Commercial Distribution

  • 74543527235258 ()
  • 14543527235256 ()
  • 04543527235259 ()

  • 2.1mm Catheter Diameter
  • 31 mm Catheter Length


  • Peripheral vascular catheter

Nova 5 - 00863593000259

The Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a solution of up to 1.0% cobalt chloride and up to 2.0% N-Acetyl cysteine, in a ratio of 1:2. Zirconium oxide is sealed within the device. The length of the polymer capsule is between 5.5 mm and 10.0 mm, and the diameter is 1.0 mm. It is loaded in an implant needle and sterilized with Ethylene Oxide.
C4 IMAGING, LLC
F-01-03-0111
In Commercial Distribution

  • 00863593000259 ()


  • Radiological image marker, implantable

Nova 5 - 00863593000242

The Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a solution of up to 1.0% cobalt chloride and up to 2.0% N-Acetyl cysteine, in a ratio of 1:2. Zirconium oxide is sealed within the device. The length of the polymer capsule is between 5.5 mm and 10.0 mm, and the diameter is between 0.9 mm and 1.2 mm.
C4 IMAGING, LLC
F-01-03-0011
In Commercial Distribution

  • 00863593000242 ()


  • Radiological image marker, implantable

RABEA 5° - 04047844014059

The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, angled
In Commercial Distribution

  • 04047844014059 ()

  • 10x12x12mm
WK101212

  • Polymeric spinal interbody fusion cage

RABEA 5° - 04047844014042

The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, angled
In Commercial Distribution

  • 04047844014042 ()

  • 9x12x12mm
WK091212

  • Polymeric spinal interbody fusion cage

NOVAL 5° - 04047844009970

The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Titanium TETRIS™. The basic shape of these implants is a hollow structural frame. The superior and inferior surfaces are open with spikes that assist with anchoring and seating the implant between the vertebral bodies. The devices are available in a variety of dimensional sizes with or without angulation thereby enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844009970 ()

  • 16x15x48mm
NV051648

  • Polymeric spinal interbody fusion cage
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