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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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ARCHITECT Intact PTH Controls
Abbott GmbH
08K2513
In Commercial Distribution

  • 00380740156022 ()
08K2513

  • Parathyroid hormone (PTH) IVD, control
Alinity I Intact PTH Controls
Abbott GmbH
08P3111
In Commercial Distribution

  • 00380740155377 ()
08P3111

  • Parathyroid hormone (PTH) IVD, control
Alinity I Intact PTH Calibrators
Abbott GmbH
08P3102
In Commercial Distribution

  • 00380740155360 ()
08P3102

  • Parathyroid hormone (PTH) IVD, calibrator
ARCHITECT STAT High Sensitivity Troponin-I Calibrators
ABBOTT IRELAND
02R9801
In Commercial Distribution

  • 00380740175474 ()
02R9801

  • Troponin I IVD, calibrator
No Description
Rti Surgical, Inc.
002590
In Commercial Distribution

  • 10885862094100 ()
602-05-90

  • Bone matrix implant, human-derived
No Description
Rti Surgical, Inc.
002575
In Commercial Distribution

  • 10885862094094 ()
602-05-75

  • Bone matrix implant, human-derived
No Description
Rti Surgical, Inc.
002529
In Commercial Distribution

  • 10885862093226 ()
600-05-90

  • Bone matrix implant, human-derived
No Description
Rti Surgical, Inc.
002545
In Commercial Distribution

  • 10885862093219 ()
600-05-45

  • Bone matrix implant, human-derived
No Description
Rti Surgical, Inc.
002530
In Commercial Distribution

  • 10885862093202 ()
600-03-30

  • Bone matrix implant, human-derived
No Description
Rti Surgical, Inc.
002523
In Commercial Distribution

  • 10885862093196 ()
600-03-20

  • Bone matrix implant, human-derived
Kit of 12 Unyvero M1 Master Mix Tubes, to be used with Unyvero LRT Cartridges
Curetis GmbH
M1 Master Mix Tube Kit
Not in Commercial Distribution

  • 04260364750041 ()
10020

  • DNA amplification enzyme reagent IVD
Optiflow Nasal Filtered Interface with CO2 Sampling Medium
FISHER & PAYKEL HEALTHCARE LIMITED
AA031JM
In Commercial Distribution

  • 09420012470959 ()
  • 09420012470942 ()

  • MEDIUM
AA031JM

  • Nasal oxygen cannula, basic
Adult Optiflow Heated Circuit Kit
FISHER & PAYKEL HEALTHCARE LIMITED
950A40J
In Commercial Distribution

  • 09420012461223 ()
  • 09420012461117 ()
950A40J

  • Ventilator breathing circuit, single-use
The Aptiva System Cleaning Solution Kit is for use on the Aptiva Multi-Analyte Instrument to clean the instrument Optical Module (OM) and flush the system.
INOVA DIAGNOSTICS, INC.
AC1003
In Commercial Distribution



  • Instrument/analyser cleaning agent IVD
Dual-curing adhesive composite
Harvard Dental International GmbH
FAFCEMWO5
In Commercial Distribution

  • EHARFAFCEMWO51 ()


  • Dental composite resin
Dual-curing adhesive composite
Harvard Dental International GmbH
FAFCEMT5
In Commercial Distribution

  • EHARFAFCEMT51 ()


  • Dental composite resin
Dual-curing adhesive composite
Harvard Dental International GmbH
FAFCEMA35
In Commercial Distribution

  • EHARFAFCEMA351 ()


  • Dental composite resin
Dual-curing adhesive composite
Harvard Dental International GmbH
FAFCEMA25
In Commercial Distribution

  • EHARFAFCEMA251 ()


  • Dental composite resin
Dual cure core build-up and post cementing composite
Harvard Dental International GmbH
7083600
In Commercial Distribution

  • EHAR70836001 ()


  • Dental composite resin
Dual cure semi-permanent luting cement
Harvard Dental International GmbH
17720
In Commercial Distribution

  • EHAR177201 ()


  • Dental composite resin
Dual Cure Translucent Temporary Cement
First Scientific Dental Materials GmbH
32-001
In Commercial Distribution

  • EFSM320010 ()


  • Zinc oxide eugenol dental cement
Premium Dual cure Core Build-up and Post Cementing Composite
First Scientific Dental Materials GmbH
12-013A2
In Commercial Distribution

  • E12013A2 ()
  • EFSM12013A20 ()


  • Dental composite resin
Semi-Permant Cement for Crowns and Bridges on Implants
First Scientific Dental Materials GmbH
12-008
In Commercial Distribution

  • EFSM120080 ()


  • Dental composite resin
Dual Cure Flowable Composite Cement
First Scientific Dental Materials GmbH
12-005A3
In Commercial Distribution

  • EFSM12005A30 ()


  • Dental composite resin
Premium Dual cure Core Build-up and Post Cementing Composite
First Scientific Dental Materials GmbH
12-001BLUE
In Commercial Distribution

  • EFSM12001BLUE0 ()


  • Dental composite resin
Premium Dual cure Core Build-up and Post Cementing Composite
First Scientific Dental Materials GmbH
12-001A3
In Commercial Distribution

  • EFSM12001A30 ()


  • Dental composite resin
Premium Dual cure Core Build-up and Post Cementing Composite
First Scientific Dental Materials GmbH
12-001A2
In Commercial Distribution

  • EFSM12001A20 ()


  • Dental composite resin
Syva® Emit® 2000 Sirolimus Calibrators
Siemens Healthcare Diagnostics Inc.
10445402
In Commercial Distribution

  • 00842768029622 ()
8S109UL

  • Rapamycin (sirolimus) therapeutic drug monitoring IVD, calibrator
Cyclosporine Extended Range Calibrator, 1x5x2mL
Siemens Healthcare Diagnostics Inc.
10445004
Not in Commercial Distribution

  • 00842768018213 ()
  • 00630414017075 ()
DC108A

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
N-Terminal Pro-Brain Natriuretic Peptide Calibrator, 2x5x1mL
Siemens Healthcare Diagnostics Inc.
10445008
In Commercial Distribution

  • 00842768016912 ()
  • 00630414017105 ()
RC423A

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator
LOCI 1 Calibrator, 2x4x1.5mL / 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10445194
In Commercial Distribution

  • 00842768016714 ()
KC660

  • Multiple thyroid marker IVD, calibrator
Myoglobin Calibrator, 2x1.5mL / 2x2.5mL / 2x2.0mL
Siemens Healthcare Diagnostics Inc.
10445191
In Commercial Distribution

  • 00842768016509 ()
KC624

  • Myoglobin IVD, calibrator
Cyclosporine Extended Range Calibrator, 3x2mL / 3x1.5ml
Siemens Healthcare Diagnostics Inc.
10445186
Not in Commercial Distribution

  • 00842768016448 ()
KC440

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
Cardiac Troponin-I Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10444986
In Commercial Distribution

  • 00842768013713 ()
  • 00630414016955 ()
RC421C

  • Troponin I IVD, calibrator
Cyclosporine Calibrator, 1x5x2mL
Siemens Healthcare Diagnostics Inc.
10445001
In Commercial Distribution

  • 00842768005213 ()
DC89

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
Tacrolimus Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10445012
Not in Commercial Distribution

  • 00842768004872 ()
DC107

  • Tacrolimus therapeutic drug monitoring IVD, calibrator
Syva® Emit® 2000 Tacrolimus Calibrators
Siemens Healthcare Diagnostics Inc.
10445399
In Commercial Distribution

  • 00842768001680 ()
8R109UL

  • Tacrolimus therapeutic drug monitoring IVD, calibrator
Emit ® 2000 Cyclosporine Specific Negative Calibrator
Siemens Healthcare Diagnostics Inc.
10445377
In Commercial Distribution

  • 00842768001475 ()
  • 00630414024523 ()
6R319UL

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control
Emit® 2000 Cyclosporine Specific Calibrators, 6 levels
Siemens Healthcare Diagnostics Inc.
10445376
In Commercial Distribution

  • 00842768001468 ()
6R119UL

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
Calibra® Bio Capsule Sample
DENTSPLY INTERNATIONAL INC.
607608
In Commercial Distribution

  • D0026076080 ()
  • D0026076081 ()

  • 3 Capsules
607608

  • Dental composite resin
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