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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NFEN Cutoff Calibrator 5 ng/mL (1 x 5 mL)
LIN-ZHI INTERNATIONAL, INC.
C68815
In Commercial Distribution

  • 00850624008360 ()
C68815

  • Fentanyl IVD, calibrator
Antibody/Substrate Reagent (R1): 100 mL Enzyme Conjugate Reagent (R2): 37.5 mL
LIN-ZHI INTERNATIONAL, INC.
C68808
In Commercial Distribution

  • 00850624008353 ()
C68808

  • Fentanyl IVD, kit, enzyme immunoassay (EIA)
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-013
In Commercial Distribution

  • 09348215031862 ()


  • Fluted surgical drill bit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-076
In Commercial Distribution

  • 09348215061807 ()


  • Fluted surgical drill bit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-075
In Commercial Distribution

  • 09348215061791 ()


  • Fluted surgical drill bit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-070
In Commercial Distribution

  • 09348215061784 ()


  • Fluted surgical drill bit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-066
In Commercial Distribution

  • 09348215061777 ()


  • Fluted surgical drill bit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-034
In Commercial Distribution

  • 09348215061739 ()


  • Fluted surgical drill bit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-033
In Commercial Distribution

  • 09348215061722 ()


  • Fluted surgical drill bit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-032
In Commercial Distribution

  • 09348215061715 ()


  • Fluted surgical drill bit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-031
In Commercial Distribution

  • 09348215061708 ()


  • Fluted surgical drill bit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-029
In Commercial Distribution

  • 09348215061685 ()


  • Fluted surgical drill bit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-028
In Commercial Distribution

  • 09348215061678 ()


  • Fluted surgical drill bit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-027
In Commercial Distribution

  • 09348215061661 ()


  • Fluted surgical drill bit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-026
In Commercial Distribution

  • 09348215061654 ()


  • Fluted surgical drill bit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-022
In Commercial Distribution

  • 09348215061647 ()


  • Fluted surgical drill bit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-024
In Commercial Distribution

  • 09348215058272 ()


  • Fluted surgical drill bit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-023
In Commercial Distribution

  • 09348215058265 ()


  • Fluted surgical drill bit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-025
In Commercial Distribution

  • 09348215058227 ()


  • Fluted surgical drill bit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-102
In Commercial Distribution

  • 09348215109424 ()


  • Fluted surgical drill bit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-101
In Commercial Distribution

  • 09348215109417 ()


  • Fluted surgical drill bit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-100
In Commercial Distribution

  • 09348215109400 ()


  • Fluted surgical drill bit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-099
In Commercial Distribution

  • 09348215109394 ()


  • Fluted surgical drill bit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-098
In Commercial Distribution

  • 09348215109387 ()


  • Fluted surgical drill bit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-097
In Commercial Distribution

  • 09348215109370 ()


  • Fluted surgical drill bit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-096
In Commercial Distribution

  • 09348215109363 ()


  • Fluted surgical drill bit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-095
In Commercial Distribution

  • 09348215109356 ()


  • Fluted surgical drill bit, reusable
No Description
ACCUTRON, INC.
34079
In Commercial Distribution

  • 00813830022070 ()
34079

  • Medical gas pipeline system
No Description
ACCUTRON, INC.
34077
In Commercial Distribution

  • 00813830022049 ()
34077

  • Medical gas pipeline system
No Description
ACCUTRON, INC.
34076
In Commercial Distribution

  • 00813830022032 ()
34076

  • Medical gas pipeline system
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