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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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Alinity m - 00884999049185

Alinity m SARS-CoV-2 Application Specification File
ABBOTT MOLECULAR INC.
09N78-03A
In Commercial Distribution

  • 00884999049185 ()
09N78-03A

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999049055

Abbott RealTime SARS-CoV-2 Application CD-ROM
ABBOTT MOLECULAR INC.
09N77-010
In Commercial Distribution

  • 00884999049055 ()
09N77-010

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999047068

Abbott RealTime ZIKA Application CD-ROM
ABBOTT MOLECULAR INC.
09N27-002
In Commercial Distribution

  • 00884999047068 ()
09N27-002

  • Laboratory instrument/analyser application software IVD

STRADIS HEALTHCARE - M7526894320

Tissue Processing Kit
STRADIS MEDICAL, LLC
689-432
Not in Commercial Distribution

  • M7526894320 ()


  • General surgical procedure kit, non-medicated, single-use

STRADIS HEALTHCARE - M7526894270

No Description
STRADIS MEDICAL, LLC
689-427
Not in Commercial Distribution

  • M7526894270 ()
  • M7526894271 ()


  • General surgical procedure kit, non-medicated, single-use

STRADIS HEALTHCARE - M7526894410

No Description
STRADIS MEDICAL, LLC
689-441
Not in Commercial Distribution

  • M7526894410 ()


  • General surgical procedure kit, non-medicated, single-use

Halyard - 10809160471289

No Description
AVID MEDICAL, INC.
RCDC35-01
In Commercial Distribution

  • 20809160471286 ()
  • 10809160471289 ()
RCDC35-01

  • General surgical procedure kit, non-medicated, single-use

Halyard - 10809160471272

No Description
AVID MEDICAL, INC.
PLDC33-01
In Commercial Distribution

  • 20809160471279 ()
  • 10809160471272 ()
PLDC33-01

  • General surgical procedure kit, non-medicated, single-use

Restoration - 08936214221165

No Description
ACESO DENTAL LABORATORY COMPANY LIMITED
116
In Commercial Distribution

  • 08936214221172 ()
  • 08936214221165 ()


  • Custom-made dental crown, metal/polymer
  • Custom-made dental crown, polymer
  • Dental bridge, metal-polymer
  • Dental bridge, polymer
  • Dental veneer, professional
  • Resin dental inlay
  • Custom-made dental crown, ceramic
  • Dental bridge, ceramic
  • Ceramic dental inlay

Restoration, splint - 06972677871587

No Description
Modern Dental Laboratory (DG) Co., Ltd.
158
In Commercial Distribution

  • 06972677871594 ()
  • 06972677871587 ()


  • Custom-made dental crown, metal/polymer
  • Custom-made dental crown, polymer
  • Dental bridge, metal-polymer
  • Dental bridge, polymer
  • Dental veneer, professional
  • Resin dental inlay
  • Removable dental occlusal splint, preformed
  • Orthodontic retainer
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