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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 SPIN SNAP-OFF SCREW is a self drilling and self tapping snap-off screw. One part is fixed on a standard surgical power equipment and when the snap-off screw is totally introduced in the bone, her head is blocked and the breaking torque is enough important to cause dissociation between the screw and the snap-off. It comes in lengths from 11 to 14mm and it is available in 2.0mm and 2.7mm diameters. It is made from Titanium alloy and it is delivered sterile.
NEWDEAL
112011SND
In Commercial Distribution

  • 10381780047322 ()
  • M248112011SND1 ()

  • 2mm diam. x 11mm length
112011SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The SPIN SNAP-OFF SCREW is a self drilling and self tapping snap-off screw. One part is fixed on a standard surgical power equipment and when the snap-off screw is totally introduced in the bone, its head is blocked and the breaking torque is important enough to cause dissociation between the screw and the snap-off. It comes in lengths from 11 to 14mm and it is available in 2.0mm and 2.7mm diameters. It is made from Titanium alloy and it is delivered non sterile.
NEWDEAL
112011ND
In Commercial Distribution

  • 10381780047315 ()
  • M248112011ND1 ()

  • 2mm diam. x 11mm length
112011ND

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Size:Tapered 10/13 mm; Type: Clear
Boston Medical Products, Inc.
721310
In Commercial Distribution

  • EBES7213100 ()
  • EBES7213101 ()

  • Outer Diameter (Upper Inner Limb): 10 mm
  • Length (Outer Limb): 72 mm
  • Outer Diameter (Outer Limb): 11 mm
  • Length (Lower Inner Limb): 76 mm
  • Length (Upper Inner Limb): 76 mm
  • Length (Inner Limb): 163 mm
  • Outer Diameter (Lower Inner Limb): 13 mm
721310

  • Trachea prosthesis
Size:Tapered 10/13 mm; Type: Radiopaque
Boston Medical Products, Inc.
71310R
In Commercial Distribution

  • EBES71310R0 ()
  • EBES71310R1 ()

  • Outer Diameter (Upper Inner Limb): 10 mm
  • Length (Outer Limb): 72 mm
  • Outer Diameter (Outer Limb): 11 mm
  • Length (Lower Inner Limb): 76 mm
  • Length (Upper Inner Limb): 76 mm
  • Length (Inner Limb): 163 mm
  • Outer Diameter (Lower Inner Limb): 13 mm
71310R

  • Trachea prosthesis
IPS Style Ceram Pow. Opaquer 870 A1, A3, A3, A3.5, Deep Dentin A1, A2, A3, A3.5, Dentin A1, A2, A3, A3.5, Incisal I1, I2, I3, I4, 1x5g each Transpa neutral, Mamelon light, Occ. Dentin orange, Opal Effect 11, One 1, 2, 3, 4, IPS Ivocolor Shade Dentin SD1, SD2, Incisal SI1, IPS Ivocolor Essence EO1 white, EO4 sunset, E10 mahogany, E16 sapphire, IPS Ivocolor Glaze Pase, IPS Ivocolor Mixing Liquids (allround), IPS Pow. Opaquer Liquid, IPS Build-Up Liquid allround, Shade Guide IPS Style Ceram Impulse, Shade Guide IPS Style Ceram Incisal /Transpa
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
679925EN
Not in Commercial Distribution

  • DIVO679925EN1 ()
679925

  • Dental appliance fabrication material, ceramic
The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The device is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy This also comprises of accessories 1) Extension cable instrument 2) Multi Instrument support 3) FootSwitch 4) PC mouse 5) Service Keyboard 6)DVI monitor cable 7) VGA monitor cable 8) Monitor cable control 9) HDMI monitor cable 10) SDI video Cable 11) Power Cable (US)
Fiagon GmbH
CUBE4D
Not in Commercial Distribution

  • EFIAE0111060 ()


  • Multi-purpose stereotactic surgery system
The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The device is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy This also comprises of accessories 1) Extension cable instrument 2) Extension Cable localizer 3) FootSwitch 4) Double Instrument support 5) PC mouse 6) Service Keyboard 7)DVI monitor cable 8) VGA monitor cable 9)Monitor cable control 10) HDMI monitor cable 11) Composite video Cable 12) Power Cable (US)
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0111031 ()
  • EFIAE0111030 ()

  • Height: 135 Millimeter
  • Width: 315 Millimeter
  • Weight: 11.7 Kilogram
  • Length: 365 Millimeter


  • Multi-purpose stereotactic surgery system
SIR-Y001 (3Gbq/5ml): SIR-Spheres Y-90 resin microspheres consist of biocompatible resin microspheres containing yttrium-90 with a size between 20 and 60 microns in diameter. Each vial contains 3 GBq of Y90 ± 10% (at the time of calibration) in a total of 5 cc water for injection. Yttrium-90 is a high-energy pure beta-emitting isotope with no primary gamma emission. The maximum energy of the beta particles is 2.27MeV with a mean of 0.93MeV. The maximum range of emissions in tissue is 11mm with a mean of 2.5mm. This is a brachytherapy product considered to be a sealed source device. The yttrium-90 has a purity specification of 999,900 ppm at reference, at (or after) time of manufacture of SIR-Spheres microspheres. The half-life is 64.1 hours. In use requiring the isotope to decay to infinity, 94% of the radiation is delivered in 11 days leaving only background radiation with no therapeutic value. SIR-Spheres microspheres themselves are a permanent implant. Each device is for single patient use.
SIRTEX MEDICAL PTY LTD
SIR-Y001
In Commercial Distribution


  • Total Volume: 5 Milliliter


  • Manual brachytherapy source, permanent implant
SIR-Y001 (3Gbq/5ml): SIR-Spheres Y90 resin microspheres consist of biocompatible resin microspheres containing yttrium-90 with a size between 20 and 60 microns in diameter. Each vial contains 3 GBq of Y90 ± 10% (at the time of calibration) in a total of 5 cc water for injection. Yttrium-90 is a high-energy pure beta-emitting isotope with no primary gamma emission. The maximum energy of the beta particles is 2.27MeV with a mean of 0.93MeV. The maximum range of emissions in tissue is 11mm with a mean of 2.5mm. This is a brachytherapy product considered to be a sealed source device. The yttrium-90 has a purity specification of 999,900 ppm at reference, at (or after) time of manufacture of SIR-Spheres microspheres. The half-life is 64.1 hours. In use requiring the isotope to decay to infinity, 94% of the radiation is delivered in 11 days leaving only background radiation with no therapeutic value. SIR-Spheres microspheres themselves are a permanent implant. Each device is for single patient use.
SIRTEX MEDICAL PTY LTD
SIR-Y001
Not in Commercial Distribution

  • M425SIRY0010 ()

  • Total Volume: 5 Milliliter


  • Manual brachytherapy source, permanent implant
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