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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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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
1600200-001
In Commercial Distribution

  • J00716002000011 ()
1600200-001

  • Dental power tool system handpiece, remotely-driven
Electric micromotors are designed to transform electricity into mechanic rotation to drive dental hand-pieces and contra-angles.
Bien-Air Dental SA
1600079-001
In Commercial Distribution

  • J00716000790011 ()
1600079-001

  • Remotely-driven dental drilling system motor
Electric micromotors are designed to transform electricity into mechanic rotation to drive dental hand-pieces and contra-angles.
Bien-Air Dental SA
1600078-001
In Commercial Distribution

  • J00716000780011 ()
1600078-001

  • Remotely-driven dental drilling system motor
Electric micromotors are designed to transform electricity into mechanic rotation to drive dental hand-pieces and contra-angles.
Bien-Air Dental SA
1600074-001
In Commercial Distribution

  • J00716000740011 ()
1600074-001

  • Remotely-driven dental drilling system motor
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
1600052-001
In Commercial Distribution

  • J00716000520011 ()
1600052-001

  • Dental power tool system handpiece, remotely-driven
Melanoma Marker (HMB45) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human HMB45 antigen in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0625
In Commercial Distribution

  • 05055331322524 ()
PA0625

  • Melanoma specific protein IVD, antibody
NCL-L-HMB45 is intended for the qualitative identification by light microscopy of human HMB45 antigen in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
HMB45-L-CE
In Commercial Distribution

  • 05055331319326 ()
NCL-L-HMB45

  • Melanoma specific protein IVD, antibody
Melanoma Marker (HMB45) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human HMB45 antigen in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0027
In Commercial Distribution

  • 05055331319104 ()
PA0027

  • Melanoma specific protein IVD, antibody
IV START KIT W/TAPE
MEDLINE INDUSTRIES, INC.
DYNDV1947
In Commercial Distribution

  • 40889942148579 ()
  • 10889942148578 ()
DYNDV1947

  • Peripheral intravenous catheterization support kit
Stainless Steel Surgical Box
AMERICAN DENTAL IMPLANT CORPORATION
SSBX
In Commercial Distribution

  • D896SSBX0 ()
SSBX

  • Dental implant/prosthesis surgical procedure kit
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