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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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Oxford Temp CEM Flexi-Trans - EFSM320010

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

  • EFSM320010 ()


  • Zinc oxide eugenol dental cement

Oxford Zircore NANO A2 - EFSM12013A20

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

Oxford Cem IMPLANT - EFSM120080

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

  • EFSM120080 ()


  • Dental composite resin

Oxford Flo CEM A3 - EFSM12005A30

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

  • EFSM12005A30 ()


  • Dental composite resin

Oxford Zircore NANO Blue - EFSM12001BLUE0

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

  • EFSM12001BLUE0 ()


  • Dental composite resin

Oxford Zircore NANO A3 - EFSM12001A30

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

  • EFSM12001A30 ()


  • Dental composite resin

Oxford Zircore NANO A2 - EFSM12001A20

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 - 00842768029622

Syva® Emit® 2000 Sirolimus Calibrators
Siemens Healthcare Diagnostics Inc.
10445402
In Commercial Distribution

  • 00842768029622 ()
8S109UL

  • Rapamycin (sirolimus) therapeutic drug monitoring IVD, calibrator

Dimension® CSAE Calibrator - 00842768018213

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

Dimension® PBNP Calibrator - 00842768016912

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

Dimension Vista® LOCI 1 CAL - 00842768016714

LOCI 1 Calibrator, 2x4x1.5mL / 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10445194
In Commercial Distribution

  • 00842768016714 ()
KC660

  • Multiple thyroid marker IVD, calibrator

Dimension Vista® MYO CAL - 00842768016509

Myoglobin Calibrator, 2x1.5mL / 2x2.5mL / 2x2.0mL
Siemens Healthcare Diagnostics Inc.
10445191
In Commercial Distribution

  • 00842768016509 ()
KC624

  • Myoglobin IVD, calibrator

Dimension Vista® CSAE CAL - 00842768016448

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

Dimension® CTNI Calibrator - 00842768013713

Cardiac Troponin-I Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10444986
In Commercial Distribution

  • 00842768013713 ()
  • 00630414016955 ()
RC421C

  • Troponin I IVD, calibrator

Dimension® CSA Calibrator - 00842768005213

Cyclosporine Calibrator, 1x5x2mL
Siemens Healthcare Diagnostics Inc.
10445001
In Commercial Distribution

  • 00842768005213 ()
DC89

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator

Dimension® TACR Calibrator - 00842768004872

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 - 00842768001680

Syva® Emit® 2000 Tacrolimus Calibrators
Siemens Healthcare Diagnostics Inc.
10445399
In Commercial Distribution

  • 00842768001680 ()
8R109UL

  • Tacrolimus therapeutic drug monitoring IVD, calibrator

Syva® Emit® 2000 Cyclosporine Specific Negative Calibrator - 00842768001475

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

Syva® Emit® 2000 Cyclosporine Specific Calibrators - 00842768001468

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 Bioceramic Luting Cement - D0026076081

Calibra® Bio Capsule Sample
DENTSPLY INTERNATIONAL INC.
607608
In Commercial Distribution

  • D0026076080 ()
  • D0026076081 ()

  • 3 Capsules
607608

  • Dental composite resin
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