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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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Dummy temple, left, black; contact star evo1
BHM-Tech Produktionsgesellschaft m.b.H.
BC3/BL/L/SW/A
In Commercial Distribution

  • 09120041050312 ()
77733340

  • Head-worn bone-conduction hearing aid
Dummy temple, right, brown; contact star evo1
BHM-Tech Produktionsgesellschaft m.b.H.
BC3/BL/R/BR/A
In Commercial Distribution

  • 09120041050305 ()
77733339

  • Head-worn bone-conduction hearing aid
Dummy temple, left, brown; contact star evo1
BHM-Tech Produktionsgesellschaft m.b.H.
BC3/BL/L/BR/A
In Commercial Distribution

  • 09120041050299 ()
77733338

  • Head-worn bone-conduction hearing aid
The xTAG® Cystic Fibrosis 60 Kit v2 is a device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens.
Luminex Molecular Diagnostics, Inc
I024C0181
In Commercial Distribution

  • 00840487100479 ()
I024C0181

  • Cystic fibrosis IVD, kit, multiplex
The xTAG® Cystic Fibrosis 39 Kit v2 is a device used to simultaneously detect and identify a panel of mutations and variants in the Cystic Fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens.
Luminex Molecular Diagnostics, Inc
I027C0231
In Commercial Distribution

  • 00840487100141 ()
I027C0231

  • Cystic fibrosis IVD, kit, multiplex
SMART MOUNT
JJGC Indústria e Comércio de Materiais Dentários S/A.
113.046
In Commercial Distribution

  • 07899878001782 ()

  • Outer Diameter: 4.3 Millimeter
  • Outer Diameter: 4.1 Millimeter
113.046

  • Dental implant/prosthesis surgical procedure kit
ScanX Classic for Intraoral & Extraoral Imaging is a device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose.
AIR TECHNIQUES, INC.
F3705
In Commercial Distribution

  • D678F37050 ()
  • D678F37001 ()
  • D678F3700U1 ()
  • D678F37051 ()
  • D678F3700C1 ()
  • D678F3750C1 ()
  • D678F37501 ()

  • Height: 24.5 Inch
  • Depth: 15.5 Inch
  • Width: 15.5 Inch
  • Weight: 51 Pound


  • Radiography digital imaging scanner
ScanX Intraoral for Centralized Imaging is a device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose.
AIR TECHNIQUES, INC.
F3605
In Commercial Distribution

  • D678F36050 ()
  • D678F36001 ()
  • D678F3600U1 ()
  • D678F36051 ()
  • D678F3600C1 ()

  • Height: 16 Inch
  • Depth: 15.5 Inch
  • Width: 15.5 Inch
  • Weight: 44 Pound
F3600

  • Radiography digital imaging scanner
The Fixation screw is a cannulated titanium alloy screw of 7.5mm diameters partially threaded and decreased thread at the head, allowing optimal compression. The screw has a self-drilling and self-tapping screw tip. These features enable its use in totally intra-osseous fixation. The screw is cannulated in order to enable the use of a K-wire for optimal positioning. Delivered sterile.
NEWDEAL
111810SND
In Commercial Distribution

  • 10381780047285 ()
  • M248111810SND1 ()

  • 7.5mm diam. x 110mm length
111810SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The Fixation screw is a cannulated titanium alloy screw of 7.5mm diameters partially threaded and decreased thread at the head, allowing optimal compression. The screw has a self-drilling and self-tapping screw tip. These features enable its use in totally intra-osseous fixation. The screw is cannulated in order to enable the use of a K-wire for optimal positioning. Delivered sterile.
NEWDEAL
111800SND
In Commercial Distribution

  • 10381780047261 ()
  • M248111800SND1 ()

  • 7.5mm diam. x 100mm length
111800SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
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