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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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N/A - 00885074494203

CD HORIZON SPIRE - INNER TRAY
MEDTRONIC SOFAMOR DANEK, INC.
9241091
In Commercial Distribution

  • 00885074494203 ()


  • Instrument tray, reusable

N/A - 00885074494197

CD HORIZON SPIRE - OUTER CASE
MEDTRONIC SOFAMOR DANEK, INC.
9241090
In Commercial Distribution

  • 00885074494197 ()


  • Instrument tray, reusable

N/A - 00885074017082

SFTWR 9731368 CD, AUTO-INSTALL, TRACER
MEDTRONIC NAVIGATION, INC.
9731368
In Commercial Distribution

  • 00885074017082 ()


  • Multi-purpose stereotactic surgery system

Guardian™ Connect - 00763000399009

KIT MMT-7820LNA GST4C LOCKOUT CD
MEDTRONIC MINIMED, INC.
MMT-7820LNA
In Commercial Distribution

  • 00763000399009 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

Nonin - 00849686072617

SenSmart Data Management software
NONIN MEDICAL, INC.
SenSmart Download Software
In Commercial Distribution

  • 00849686074796 ()
  • 00849686072617 ()


  • Medical equipment clinical data interfacing software

ADULT LIMB RECONSTRUCTION SYSTEM - 18033509858093

PLASTIC NUT FOR CD WITH CLICKER AND CD GARCHES (PACK OF 5 OF EACH)
ORTHOFIX SRL
1
In Commercial Distribution

  • 18033509858093 ()
950086M

  • External orthopaedic fixation system, reusable

BioPlex 2200 - 00847865002394

Vasculitis Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4 V2
In Commercial Distribution

  • 00847865002394 ()

  • 1 Each
6651870D

  • Multiple vasculitis-associated antibody IVD, kit, multiplex

BioPlex 2200 - 00847865002288

Anti-CCP Assay Protocol File CD, SW4_v3
BIO-RAD LABORATORIES, INC.
SW4_V3
In Commercial Distribution

  • 00847865002288 ()

  • 1 Each
6653270D

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, multiplex

BioPlex 2200 - 00847865000826

CD, BioPlex Anti-CCP Calibrator Lot Data
BIO-RAD LABORATORIES, INC.
6633220
In Commercial Distribution

  • 00847865000826 ()

  • 1 Each
6633220

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, calibrator

BioPlex 2200 - 00847865010955

Vasculitis Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1 V1
In Commercial Distribution

  • 00847865010955 ()

  • 1 Each
6651870E

  • Multiple vasculitis-associated antibody IVD, kit, multiplex
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