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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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Probe
FUJIFILM CORPORATION
EUP-O53T
In Commercial Distribution



  • Surgical ultrasound imaging transducer
Probe
FUJIFILM CORPORATION
EUP-F531
In Commercial Distribution



  • Surgical ultrasound imaging transducer
Probe
FUJIFILM CORPORATION
EUP-F334
In Commercial Distribution



  • Surgical ultrasound imaging transducer
Cysto Bridge
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
26068 CD
In Commercial Distribution

  • 00848657011198 ()


  • Rigid optical cystoscope
Frazier Suction Tube, RoundSlot
Avalign Technologies, Inc.
CD 70-1089
In Commercial Distribution

  • 00190776094959 ()


  • Surgical/emergency suction cannula, non-illuminating, reusable
Cervical Disc Prep Tray
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557207885 ()
CD.1000

  • General internal orthopaedic fixation system implantation kit
iQ®200 Body Fluids Module (CD only)
BECKMAN COULTER IRELAND INC.
Body Fluids Module
In Commercial Distribution

  • 10837461002475 ()
800-3704

  • Laboratory instrument/analyser application software IVD
BPX Syph Total& RPR Mnl&CD SW4.3 v5
BIO-RAD LABORATORIES, INC.
SW4.3 v5.0
In Commercial Distribution

  • 03610522207992 ()

  • 1 Each
12014549

  • Treponema pallidum total antibody IVD, kit, fluorescent immunoassay
Rubella & CMV IgM Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_V1
Not in Commercial Distribution

  • 00847865011006 ()

  • 1 Each
6653870D

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
BioPlex 2200 Anti-CCP Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_V1
In Commercial Distribution

  • 00847865010986 ()

  • 1 Each
6653270E

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