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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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BioFire® Respiratory Panel 2.1-EZ EUA, 30 Tests - 00815381020239

IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
423883
In Commercial Distribution

  • 00815381020239 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Denture, Restoration - 08936214223343

No Description
ACESO DENTAL LABORATORY COMPANY LIMITED
334
In Commercial Distribution

  • 08936214223350 ()
  • 08936214223343 ()


  • Partial 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
  • Dental bridge, metal-ceramic
  • Custom-made dental crown, metal/ceramic

Denture, restoration - 06972677873567

No Description
Modern Dental Laboratory (DG) Co., Ltd.
356
In Commercial Distribution

  • 06972677873574 ()
  • 06972677873567 ()


  • Partial 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
  • Dental bridge, metal-ceramic
  • Custom-made dental crown, metal/ceramic

Denture, Restoration - 08936214221325

No Description
ACESO DENTAL LABORATORY COMPANY LIMITED
132
In Commercial Distribution

  • 08936214221332 ()
  • 08936214221325 ()


  • Partial 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 - 06972677871488

No Description
Modern Dental Laboratory (DG) Co., Ltd.
148
In Commercial Distribution

  • 06972677871495 ()
  • 06972677871488 ()


  • Partial 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

ORTHO - 10758750007523

Auto Reader IV
ORTHO-CLINICAL DIAGNOSTICS, INC.
6902093
In Commercial Distribution

  • 10758750007523 ()
6902093

  • Microplate reader IVD, automated/semi-automated

Denture, Restoration - 08936214223183

No Description
ACESO DENTAL LABORATORY COMPANY LIMITED
318
In Commercial Distribution

  • 08936214223190 ()
  • 08936214223183 ()


  • 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
  • Dental bridge, metal-ceramic
  • Custom-made dental crown, metal/ceramic

Denture, restoration - 06972677873260

No Description
Modern Dental Laboratory (DG) Co., Ltd.
326
In Commercial Distribution

  • 06972677873277 ()
  • 06972677873260 ()


  • 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
  • Dental bridge, metal-ceramic
  • Custom-made dental crown, metal/ceramic

ORTHO - 10758750005581

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

  • 10758750005581 ()
936480

  • Enzyme immunoassay (EIA) analyser IVD

ORTHO - 10758750005451

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

  • 10758750005451 ()
936396

  • Enzyme immunoassay (EIA) analyser IVD
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