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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

  • 04047844000847 ()

  • 12x38mm
SK101238

  • Polymeric spinal interbody fusion cage
Neuro Guidewire with Hydrophilic Coating
Stryker Corporation
M00316330
In Commercial Distribution

  • 07613252187165 ()

  • Length: 300.0 Centimeter
  • Outer Diameter: 0.01 Inch
1633

  • Cardiac/peripheral vascular guidewire, single-use
No Description
BIOGENEX LABORATORIES
MU201-UC
In Commercial Distribution

  • 00810119676207 ()

  • Total Volume: 1 Milliliter
MU201-UC

  • Cytokeratin IVD, antibody
InTENSity 10 Digital TENS
COMPASS HEALTH BRANDS CORP.
DI1010
In Commercial Distribution

  • 80813520011939 ()
  • 00813520011933 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Neuro Guidewire with Hydrophilic Coating
Stryker Corporation
M00316310
In Commercial Distribution

  • 07613252187158 ()

  • Outer Diameter: 0.01 Inch
  • Length: 200.0 Centimeter
1631

  • Cardiac/peripheral vascular guidewire, single-use
1 Tip Straight Microcatheter
Stryker Corporation
M0031351100
In Commercial Distribution

  • 07613252187035 ()

  • Length: 175.0 Centimeter
  • Distal Length: 20.0 Centimeter
135110

  • Vascular microcatheter
Sterilizer,steam
TUTTNAUER ISRAEL LTD.
T-Edge 10
In Commercial Distribution

  • 07290110640651 ()
AMS10-120-T

  • Steam sterilizer
Sterilizer,steam
TUTTNAUER ISRAEL LTD.
T-Edge 10
In Commercial Distribution

  • 07290110640644 ()
AMS10-120-W-T

  • Steam sterilizer
Sterilizer, steam
TUTTNAUER ISRAEL LTD.
T-Edge 10
In Commercial Distribution

  • 07290110640439 ()
AMS10-230-T

  • Steam sterilizer
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