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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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Laboratory component for prior generation Vistafix
Cochlear Bone Anchored Solutions AB
90794
In Commercial Distribution

  • 09321502015790 ()

  • 10 mm long guide pin
  • Length: 10 Millimeter
90794

  • General external orthopaedic fixation system implantation kit, single-use
to be used to attach Impression copings to abutments and Abutment replicas when making an impression of the implant site and a cast for the prosthesis
Cochlear Bone Anchored Solutions AB
90794
In Commercial Distribution

  • 09321502063395 ()


  • General external orthopaedic fixation system implantation kit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
132-16-0090
In Commercial Distribution

  • 09348215067045 ()


  • Orthopaedic implant driver
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-110
In Commercial Distribution

  • 09348215074739 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-201-510
In Commercial Distribution

  • 09348215073589 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
132-112-186
In Commercial Distribution

  • 09348215068363 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
The Global Reference Module 10 provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference Connection on the ATLAS Combo Board.
NEURALYNX, INC.
Global Reference Module - 10
In Commercial Distribution

  • 00850011306604 ()
31-0604-0052

  • Electroencephalographic signal amplifier
No Description
Icad, Inc.
D4D0223
In Commercial Distribution

  • 00850008977220 ()


  • Radiology DICOM image processing application software
No Description
Icad, Inc.
D4D0222
In Commercial Distribution

  • 00850008977213 ()


  • Radiology DICOM image processing application software
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600385-001
In Commercial Distribution

  • J00716003850011 ()
1600385-001

  • Dental power tool system handpiece, remotely-driven
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