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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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ORTHO - 10758750005451

OSP Workstation, 166 MHz (computer)
ORTHO-CLINICAL DIAGNOSTICS, INC.
936396
In Commercial Distribution

  • 10758750005451 ()
936396

  • Enzyme immunoassay (EIA) analyser IVD

ORTHO - 10758750005581

Ortho Summit Processor (OSP)
ORTHO-CLINICAL DIAGNOSTICS, INC.
936480
In Commercial Distribution

  • 10758750005581 ()
936480

  • Enzyme immunoassay (EIA) analyser IVD

Minimally Invasive Deformity Correction (MID-C) System - 07290018128046

No Description
APIFIX LTD
MID-C 125
In Commercial Distribution

  • 07290018128046 ()


  • Spinal distraction rod, mechanical

Minimally Invasive Deformity Correction (MID-C) System - 07290018128039

No Description
APIFIX LTD
MID-C 115
In Commercial Distribution

  • 07290018128039 ()


  • Spinal distraction rod, mechanical

Minimally Invasive Deformity Correction (MID-C) System - 07290018128022

No Description
APIFIX LTD
MID-C 105
In Commercial Distribution

  • 07290018128022 ()


  • Spinal distraction rod, mechanical

Minimally Invasive Deformity Correction (MID-C) System - 07290018128015

No Description
APIFIX LTD
MID-C 95
In Commercial Distribution

  • 07290018128015 ()


  • Spinal distraction rod, mechanical

Minimally Invasive Deformity Correction (MID-C) System - 07290018128008

No Description
APIFIX LTD
MID-C 85
In Commercial Distribution

  • 07290018128008 ()


  • Spinal distraction rod, mechanical

ORTHO - 10758750011582

ORTHO VERSEIA™ Pipetter Workstation - computer
ORTHO-CLINICAL DIAGNOSTICS, INC.
6842852
In Commercial Distribution

  • 10758750011582 ()
6842852

  • Enzyme immunoassay (EIA) analyser IVD

Denture, Restoration - 08936214223244

No Description
ACESO DENTAL LABORATORY COMPANY LIMITED
324
In Commercial Distribution

  • 08936214223251 ()
  • 08936214223244 ()


  • Complete upper denture
  • Complete lower denture
  • Custom-made dental crown, metal/polymer
  • Custom-made dental crown, polymer
  • Dental bridge, metal-polymer
  • Dental bridge, polymer
  • Dental veneer, professional
  • Resin dental inlay

Denture, Restoration - 08936214221189

No Description
ACESO DENTAL LABORATORY COMPANY LIMITED
118
In Commercial Distribution

  • 08936214221196 ()
  • 08936214221189 ()


  • Complete upper denture
  • Complete lower denture
  • Custom-made dental crown, metal/polymer
  • Custom-made dental crown, polymer
  • Dental bridge, metal-polymer
  • Dental bridge, polymer
  • Dental veneer, professional
  • Resin dental inlay
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