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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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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
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
No Description
JOINT RESTORATION FOUNDATION INC
1
In Commercial Distribution

  • 00860424000259 ()
PSP-101

  • Tendon graft
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
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