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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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Screw Dental Implant 3.5mm in diameter and 20mm in length
Suncoast Dental, Inc
Screw/3.5 x 20
In Commercial Distribution

  • 00083208535208 ()

  • Length: 20 Millimeter
  • Outer Diameter: 3.5 Millimeter
  • Screw 3.5mm Diameter x 20mm length
IS 3.5 x 20mm

  • Screw endosteal dental implant, two-piece
Screw Dental Implant 3.5mm in diameter and 17mm in length
Suncoast Dental, Inc
Screw/3.5 x 17
In Commercial Distribution

  • 00083208535178 ()

  • Length: 17 Millimeter
  • Screw 3.5mm Diameter x 17mm length
  • Outer Diameter: 3.5 Millimeter
IS 3.5 x 17mm

  • Screw endosteal dental implant, two-piece
Screw Dental Implant 3.5mm in diameter and 14mm in length
Suncoast Dental, Inc
Screw/3.5 x 14
In Commercial Distribution

  • 00083208535147 ()

  • Screw 3.5mm Diameter x 14mm length
  • Outer Diameter: 3.5 Millimeter
  • Length: 14 Millimeter
IS 3.5 x 14mm

  • Screw endosteal dental implant, two-piece
Screw Dental Implant 8.0mm in diameter and 17mm in length
Suncoast Dental, Inc
Screw/8.0 x 17
In Commercial Distribution

  • 00083208517808 ()

  • Length: 17 Millimeter
  • Outer Diameter: 8 Millimeter
  • Screw 8.0mm Diameter x 17mm Length
IS 8.0 x 17mm

  • Screw endosteal dental implant, two-piece
IS 3800
Dental Imaging Technologies Corporation
5943725
In Commercial Distribution

  • 00693856000043 ()
5943725

  • Intraoral optical scanning system
IS Type
Neobiotech. co., ltd
ISRSB43
In Commercial Distribution

  • 08800329740142 ()


  • Dental implant system
IS, Ø5.5
Neobiotech. co., ltd
PTAP55FS
In Commercial Distribution

  • 08809815655830 ()


  • Fixture/appliance dental drill bit, reusable
IS, Ø4.0
Neobiotech. co., ltd
PTAP40FL
In Commercial Distribution

  • 08809815655816 ()


  • Fixture/appliance dental drill bit, reusable
IS, Ø4.5
Neobiotech. co., ltd
PTAP45FL
In Commercial Distribution

  • 08809815655809 ()


  • Fixture/appliance dental drill bit, reusable
IS, Ø5.0
Neobiotech. co., ltd
PTAP50FL
In Commercial Distribution

  • 08809815655793 ()


  • Fixture/appliance dental drill bit, reusable
IS, Ø5.5
Neobiotech. co., ltd
PTAP55FL
In Commercial Distribution

  • 08809815655786 ()


  • Fixture/appliance dental drill bit, reusable
IS KIT
KURARAY NORITAKE DENTAL INC.
109-0020KA
In Commercial Distribution

  • EKUR1090020KA0 ()


  • Dental appliance fabrication material, ceramic
The DiLumen Is is a sterile, single patient use, disposable instrument that consists of a pistol style handle, a flexible 5mm shaft with an articulating section at the distal end, and scissor blades. The handle incorporates controls that enable one-handed operation of the device, including rotating the shaft; opening, closing and rotating the blades independently from the shaft; articulating the distal end of the shaft in a specific plane; and locking the articulation in a fixed position. The DiLumen Is has a plug at the bottom of the handle that can be used to connect the device to an electrosurgical generator via a dedicated cord. When the device is connected to the generator, monopolar current can be applied through the blades to cut or cauterize tissue electrosurgically
LUMENDI LLC
DiLumen Is 95 cm
In Commercial Distribution

  • 00865309000270 ()
D-3100

  • Flexible endoscopic scissors, single-use
The DiLumen Is is a sterile, single patient use, disposable instrument that consists of a pistol style handle, a flexible 5mm shaft with an articulating section at the distal end, and scissor blades. The handle incorporates controls that enable one-handed operation of the device, including rotating the shaft; opening, closing and rotating the blades independently from the shaft; articulating the distal end of the shaft in a specific plane; and locking the articulation in a fixed position. The DiLumen Is has a plug at the bottom of the handle that can be used to connect the device to an electrosurgical generator via a dedicated cord. When the device is connected to the generator, monopolar current can be applied through the blades to cut or cauterize tissue electrosurgically
LUMENDI LLC
DiLumen Is 140 cm
In Commercial Distribution

  • 00865309000263 ()
D-3101

  • Flexible endoscopic scissors, single-use
Convenience Kit. Short-term patient positioning and stabilization device during invasive and noninvasive procedures to be used on intact patient's skin. Non-Sterile and not to be used in the sterile field.
Pearl Technology AG
Positioning KIT IS Basic
In Commercial Distribution

  • 07640178061668 ()
5014

  • Radiological general body-part positioner
Convenience Kit. Short-term patient positioning and stabilization device during invasive and noninvasive procedures to be used on intact patient's skin. Non-Sterile and not to be used in the sterile field.
Pearl Technology AG
Positioning KIT IS Advanced
In Commercial Distribution

  • 07640178061651 ()
5013

  • Radiological general body-part positioner
HEARTRAIL III Guiding Catheter
TERUMO CORPORATION
40-6384
In Commercial Distribution

  • 54987350423851 ()
  • 04987350423856 ()

  • Shape name of distal shaft is IR1.5(SH)
  • Length: 100 Centimeter
  • Outer Diameter: 2.06 Millimeter
  • Pressure: 4826 KiloPascal
  • Lumen/Inner Diameter: 1.80 Millimeter
GC-U6IR150A

  • Vascular guide-catheter, single-use
HEARTRAIL III Guiding Catheter
TERUMO CORPORATION
40-6377
In Commercial Distribution

  • 54987350423837 ()
  • 04987350423832 ()

  • Shape name of distal shaft is IL3.75(SH)
  • Lumen/Inner Diameter: 1.80 Millimeter
  • Pressure: 4826 KiloPascal
  • Outer Diameter: 2.06 Millimeter
  • Length: 100 Centimeter
GC-U6IL3G0A

  • Vascular guide-catheter, single-use
HEARTRAIL III Guiding Catheter
TERUMO CORPORATION
40-6385
In Commercial Distribution

  • 54987350423813 ()
  • 04987350423818 ()

  • Shape name of distal shaft is IR2.0(SH)
  • Length: 100 Centimeter
  • Pressure: 4826 KiloPascal
  • Lumen/Inner Diameter: 1.80 Millimeter
  • Outer Diameter: 2.06 Millimeter
GC-U6IR200A

  • Vascular guide-catheter, single-use
HEARTRAIL III Guiding Catheter
TERUMO CORPORATION
40-6383
In Commercial Distribution

  • 54987350423790 ()
  • 04987350423795 ()

  • Lumen/Inner Diameter: 1.80 Millimeter
  • Pressure: 4826 KiloPascal
  • Outer Diameter: 2.06 Millimeter
  • Shape name of distal shaft is IR1.0(SH)
  • Length: 100 Centimeter
GC-U6IR100A

  • Vascular guide-catheter, single-use
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