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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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HbA1c Advanced
BECKMAN COULTER IRELAND INC.
B93009
In Commercial Distribution

  • 15099590012120 ()


  • Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry
Latex immunoassay for the determination of the C-Reactive Protein (CRP) concentration in serum and plasma on VITROS® 4600 Chemistry System and VITROS® 5600 Integrated System. The assay is intended for professional use only. For In Vitro diagnostic use only.
SENTINEL CH. SPA
115646
In Commercial Distribution

  • 08058056681911 ()

  • Total Volume: 104 Milliliter
115646

  • C-reactive protein (CRP) IVD, reagent
Wound Matrix
REPRISE BIOMEDICAL, INC.
3000
In Commercial Distribution

  • 00857072005316 ()

  • Length: 2 Centimeter
  • Width: 2 Centimeter
  • Height: 2 Centimeter


  • Collagen wound matrix dressing
Darkroom automated x-ray film processor
PROTEC GmbH & Co. KG
1190
In Commercial Distribution

  • 04260502640005 ()
1190-2-1000

  • Darkroom automated x-ray film processor
Common Ø7.0/ L=32.8
Megagen Implant Co. Ltd
SPLT02
In Commercial Distribution

  • 08809728993159 ()
SPLT02

  • Fixture/appliance dental drill bit, reusable
No Description
TOKYO BOEKI MEDISYS INC.
30-27-0905
In Commercial Distribution

  • 04580262040076 ()
30-27-0905

  • Multiple electrolyte IVD, calibrator
No Description
TOKYO BOEKI MEDISYS INC.
20-27-0478
In Commercial Distribution

  • 04580262010314 ()
20-27-0478

  • Multiple electrolyte IVD, calibrator
Standard Pre-shaped Guidewire with Hydrophilic Coating
Stryker Corporation
M00326520
In Commercial Distribution

  • 04546540688798 ()

  • Outer Diameter: 0.014 Inch
  • Length: 300.0 Centimeter
2652

  • Cardiac/peripheral vascular guidewire, single-use
Standard Guidewire with Hydrophilic Coating
Stryker Corporation
M00326510
In Commercial Distribution

  • 04546540688781 ()

  • Outer Diameter: 0.014 Inch
  • Length: 300.0 Centimeter
2651

  • Cardiac/peripheral vascular guidewire, single-use
Standard Pre-shaped Guidewire with Hydrophilic Coating
Stryker Corporation
M00326420
In Commercial Distribution

  • 04546540688774 ()

  • Outer Diameter: 0.014 Inch
  • Length: 200.0 Centimeter
2642

  • Cardiac/peripheral vascular guidewire, single-use
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