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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

  • 04047844002186 ()

  • 16x43mm
SK151643

  • 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

  • 04047844002179 ()

  • 14x43mm
SK151443

  • Polymeric spinal interbody fusion cage
No Description
DFIX
01
In Commercial Distribution

  • 08800125000037 ()

  • Wound size 15 to 20cm


  • Skin-closing tension device
KIATO Sterile CE carbon Steel Surgical Blade Box of 100 size 15. Sterilized by Gamma Irradiation.
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
15
In Commercial Distribution

  • 28902895111150 ()
  • 08902895111156 ()
11115

  • Manual scalpel blade, single-use
KIATO PLUS Sterile Carbon Steel Rib Back Surgical Blade Box of 100 size 15. Sterilized by Gamma irradiation.
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
15
In Commercial Distribution

  • 28902895182150 ()
  • 08902895182156 ()
18215

  • Manual scalpel blade, single-use
KIATO PLUS Sterile Stainless Steel Surgical Blade box of 100 Size 15. Sterilized by Gamma Irradiation.
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
15
In Commercial Distribution

  • 08902895181159 ()
  • 28902895181153 ()
18115

  • Manual scalpel blade, single-use
KIATO PLUS Sterile Carbon steel Surgical Blade box of 100 size 15. Sterilized by Gamma irradiation.
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
15
In Commercial Distribution

  • 28902895180156 ()
  • 08902895180152 ()
18015

  • Manual scalpel blade, single-use
KIATO Plus Sterile Safety Scalpel Stainless Steel Box of 10 size 15. Sterilized using ethylene oxide.
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
15
In Commercial Distribution

  • 28902895129155 ()
  • 08902895129151 ()
12915

  • Scalpel, single-use
Carbon Steel Surgical Blade,15#,100pcs/box
Sterilance Medical (Suzhou) Inc.
15#
In Commercial Distribution

  • 06945630105562 ()
  • 16945630105569 ()


  • Manual scalpel blade, single-use
No Description
Sterilance Medical (Suzhou) Inc.
15#
In Commercial Distribution

  • 36945630112417 ()
  • 16945630112413 ()
  • 06945630112416 ()


  • Manual scalpel blade, single-use
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