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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 KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame with tapered edges. The frame is made from PEEK-OPTIMA®. SEMIAL® spinal implants have a semi-cylindrical form and are hollow. The implant is made from PEEK-OPTIMA®. The provision of varying heights, together with a wedge shaped option, allow better lordosis control. The TETRIS® implants (PEEK and Titanium) are hollow having a rectangular frame with lateral fenestrations. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. These implants are available in a variety of dimensional and angular sizes. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition. The MOBIS, NOVAL, SEMIAL and PEEK TETRIS devices are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral marker pins are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3 or tantalum as described by ASTM F560. The Titanium TETRIS devices are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3. The KIMBA® and KIMBA® mini devices are manufactured from ECF PEEK OPTIMA (Invibio™).
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844000861 ()

  • 14x38mm
SK101438

  • Polymeric spinal interbody fusion cage
The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame with tapered edges. The frame is made from PEEK-OPTIMA®. SEMIAL® spinal implants have a semi-cylindrical form and are hollow. The implant is made from PEEK-OPTIMA®. The provision of varying heights, together with a wedge shaped option, allow better lordosis control. The TETRIS® implants (PEEK and Titanium) are hollow having a rectangular frame with lateral fenestrations. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. These implants are available in a variety of dimensional and angular sizes. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition. The MOBIS, NOVAL, SEMIAL and PEEK TETRIS devices are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral marker pins are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3 or tantalum as described by ASTM F560. The Titanium TETRIS devices are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3. The KIMBA® and KIMBA® mini devices are manufactured from ECF PEEK OPTIMA (Invibio™).
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844000854 ()

  • 12x43mm
SK101243

  • Polymeric spinal interbody fusion cage
The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame with tapered edges. The frame is made from PEEK-OPTIMA®. SEMIAL® spinal implants have a semi-cylindrical form and are hollow. The implant is made from PEEK-OPTIMA®. The provision of varying heights, together with a wedge shaped option, allow better lordosis control. The TETRIS® implants (PEEK and Titanium) are hollow having a rectangular frame with lateral fenestrations. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. These implants are available in a variety of dimensional and angular sizes. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition. The MOBIS, NOVAL, SEMIAL and PEEK TETRIS devices are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral marker pins are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3 or tantalum as described by ASTM F560. The Titanium TETRIS devices are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3. The KIMBA® and KIMBA® mini devices are manufactured from ECF PEEK OPTIMA (Invibio™).
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844000847 ()

  • 12x38mm
SK101238

  • Polymeric spinal interbody fusion cage
The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame with tapered edges. The frame is made from PEEK-OPTIMA®. SEMIAL® spinal implants have a semi-cylindrical form and are hollow. The implant is made from PEEK-OPTIMA®. The provision of varying heights, together with a wedge shaped option, allow better lordosis control. The TETRIS® implants (PEEK and Titanium) are hollow having a rectangular frame with lateral fenestrations. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. These implants are available in a variety of dimensional and angular sizes. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition. The MOBIS, NOVAL, SEMIAL and PEEK TETRIS devices are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral marker pins are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3 or tantalum as described by ASTM F560. The Titanium TETRIS devices are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3. The KIMBA® and KIMBA® mini devices are manufactured from ECF PEEK OPTIMA (Invibio™).
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844000830 ()

  • 10x43mm
SK101043

  • Polymeric spinal interbody fusion cage
The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame with tapered edges. The frame is made from PEEK-OPTIMA®. SEMIAL® spinal implants have a semi-cylindrical form and are hollow. The implant is made from PEEK-OPTIMA®. The provision of varying heights, together with a wedge shaped option, allow better lordosis control. The TETRIS® implants (PEEK and Titanium) are hollow having a rectangular frame with lateral fenestrations. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. These implants are available in a variety of dimensional and angular sizes. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition. The MOBIS, NOVAL, SEMIAL and PEEK TETRIS devices are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral marker pins are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3 or tantalum as described by ASTM F560. The Titanium TETRIS devices are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3. The KIMBA® and KIMBA® mini devices are manufactured from ECF PEEK OPTIMA (Invibio™).
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844000823 ()

  • 10x38mm
SK101038

  • Polymeric spinal interbody fusion cage
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

  • 04047844008379 ()

  • 18x15x48mm
NV101848

  • Polymeric spinal interbody fusion cage
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

  • 04047844008362 ()

  • 18x15x44mm
NV101844

  • Polymeric spinal interbody fusion cage
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

  • 04047844008355 ()

  • 16x15x48mm
NV101648

  • Polymeric spinal interbody fusion cage
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

  • 04047844008331 ()

  • 14x15x48mm
NV101448

  • Polymeric spinal interbody fusion cage
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

  • 04047844008317 ()

  • 12x15x48mm
NV101248

  • Polymeric spinal interbody fusion cage
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

  • 04047844008300 ()

  • 12x15x44mm
NV101244

  • Polymeric spinal interbody fusion cage
Gold based noble metal
ARGEN CORPORATION, THE
101920
In Commercial Distribution

  • D818101920 ()
101920

  • Dental casting noble alloy
No Description
BIOTRONIK SE & Co. KG
394500
In Commercial Distribution

  • 04035479131609 ()
394500

  • Cardiac pulse generator analyser cable, single-use
A blood bag temperature monitor for use by health care providers to determine if blood or blood products have reached or exceeded the indication temperature.
Temptime Corporation
STV10
In Commercial Distribution

  • 20852282007147 ()
  • 10852282007140 ()
  • 00852282007143 ()
7201-50

  • Medical product temperature point indicator, thermochemical
No Description
EYEVAN INC.
NO.9 5(48) 48 13S-CL
In Commercial Distribution

  • 04582669019167 ()


  • Tinted non-prescription spectacles
No Description
EYEVAN INC.
NO.9 5(48) 48 11S-CL
In Commercial Distribution

  • 04582669019143 ()


  • Tinted non-prescription spectacles
No Description
EYEVAN INC.
NO.9 5(48) 48 4S-CL
In Commercial Distribution

  • 04582669019136 ()


  • Tinted non-prescription spectacles
No Description
EYEVAN INC.
NO.9 5(48) 48 15S-CL
In Commercial Distribution

  • 04582669019181 ()


  • Tinted non-prescription spectacles
No Description
EYEVAN INC.
NO.9 5(48) 48 12S-CL
In Commercial Distribution

  • 04582669019150 ()


  • Tinted non-prescription spectacles
2 Tip Straight Microcatheter
Stryker Corporation
M0031351090
In Commercial Distribution

  • 04546540688071 ()

  • Length: 150.0 Centimeter
  • Distal Length: 3.0 Centimeter
135109

  • Vascular microcatheter
1 Tip Straight Microcatheter
Stryker Corporation
M0031351020
In Commercial Distribution

  • 04546540688064 ()

  • Distal Length: 15.0 Centimeter
  • Length: 155.0 Centimeter
135102

  • Vascular microcatheter
AIR 10 TUBING ELBOW
RESMED PTY LTD
37394
In Commercial Distribution

  • 00619498373949 ()
37394

  • Ventilator breathing circuit, reusable
AIR 10 PSU 90W
RESMED PTY LTD
37344
In Commercial Distribution

  • 00619498373444 ()
37344

  • Home CPAP unit
AIR 10 SIDE COVER GRAY
RESMED PTY LTD
37335
In Commercial Distribution

  • 00619498373352 ()
37335

  • Home CPAP unit
AIR 10 AIR OUTLET
RESMED PTY LTD
37310
In Commercial Distribution

  • 00619498373109 ()
37310

  • Home CPAP unit
AIR 10 90W PSU
RESMED PTY LTD
37309
In Commercial Distribution

  • 00619498373093 ()
37309

  • Home CPAP unit
AIR 10 SIDE COVER CHARCOAL
RESMED PTY LTD
37303
In Commercial Distribution

  • 00619498373031 ()
37303

  • Home CPAP unit
AIR 10 OXIMETRY MODULE
RESMED PTY LTD
37302
In Commercial Distribution

  • 00619498373024 ()
37302

  • Home CPAP unit
AIR 10 USB MODULE
RESMED PTY LTD
37301
In Commercial Distribution

  • 00619498373017 ()
37301

  • Home CPAP unit
DC-DC CONVERTER
RESMED PTY LTD
37297
In Commercial Distribution

  • 00619498372973 ()
37297

  • Portable electric ventilator
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