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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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Ceph attachment with sensor
MIDMARK CORPORATION
C6000
In Commercial Distribution

  • 00841709102752 ()
C6000

  • Stationary cephalometric x-ray system, digital
No Description
Paradigm Spine GmbH
RAT20500
In Commercial Distribution

  • 04260148897689 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Paradigm Spine GmbH
HAT50005
In Commercial Distribution

  • 04260148896613 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Paradigm Spine GmbH
DAT50005
In Commercial Distribution

  • 04260148893322 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Simplex® HV with Gentamicin is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. Simplex® HV with Gentamicinn cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. Simplex® HV with Gentamicin does not emit a signal and does not pose a safety risk in a magnetic resonance environment.
OSARTIS GmbH
6195-1-001
In Commercial Distribution

  • 24260056885765 ()
  • 14260056885768 ()
  • 04260056885761 ()

  • Total Volume: 20 Milliliter
  • Weight: 40.8 Gram
6195-1-010

  • Orthopaedic cement, antimicrobial
Syvek Brace with Straps
Marine Polymer Technologies, Inc.
420-05
In Commercial Distribution

  • 10389142000039 ()
  • 00389142000032 ()


  • Wrist immobilizer, single-use
AuDX branded Sentiero
PATH medical GmbH
100098-AU
In Commercial Distribution

  • 04260223143281 ()


  • Evoked-potential audiometer
The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that have been exposed in place of x-ray film and allows those images to be displayed on a personal computer display.
AIR TECHNIQUES, INC.
D5000QB
In Commercial Distribution

  • D678D5000QB0 ()
  • D678D5000QB1 ()

  • Weight: 43 Pound
  • Height: 14 Inch
  • Length: 18 Inch
  • Width: 15.5 Inch


  • Radiography digital imaging scanner
The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that have been exposed in place of x-ray film and allows those images to be displayed on a personal computer display.
AIR TECHNIQUES, INC.
D5000FB
In Commercial Distribution

  • D678D5000FB0 ()
  • D678D5000FB1 ()

  • Weight: 43 Pound
  • Height: 14 Inch
  • Length: 18 Inch
  • Width: 15.5 Inch


  • Radiography digital imaging scanner
No Description
Noras MRI products GmbH
13
In Commercial Distribution

  • 04251269201516 ()
113120

  • MRI system coil, radio-frequency
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