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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No Description
Roche Diagnostics GmbH
11776240322
In Commercial Distribution

  • 04015630918409 ()
11776240322

  • Cancer antigen 125 (CA125) IVD, calibrator
No Description
Roche Diagnostics GmbH
3045846122
In Commercial Distribution

  • 04015630918225 ()
3045846122

  • Cancer antigen 15-3 (CA15-3) IVD, calibrator
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211148 ()


  • Cancer antigen 125 (CA125) IVD, calibrator
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211117 ()


  • Cancer antigen 19-9 (CA19-9) IVD, calibrator
Set of Optima contre angle and licence code for settings
Bien-Air Dental SA
1700733-001
In Commercial Distribution

  • J00717007330011 ()
1700733-001

  • Surgical power tool system control unit, line-powered
Sets of iOptima systems and their dental micromotors plus relevant accessories
Bien-Air Dental SA
1700569-001
In Commercial Distribution

  • J00717005690011 ()
1700569-001

  • Surgical power tool system control unit, line-powered
Sets of Chiropro systems and their dental micromotors or contra-angles plus relevant accessories
Bien-Air Dental SA
1700388-001
In Commercial Distribution

  • J00717003880011 ()
1700388-001

  • Surgical power tool system control unit, line-powered
Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an electric or air micromotor.
Bien-Air Dental SA
1601236-001
In Commercial Distribution

  • J00716012360011 ()


  • Dental laboratory drilling system handpiece
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
1601164-001
In Commercial Distribution

  • J00716011640011 ()
1601164-001

  • Dental laboratory drilling system handpiece
CA & 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
1601138-001
In Commercial Distribution

  • J00716011380011 ()
1601138-001

  • Dental power tool system handpiece, remotely-driven
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