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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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PORTABLE WORKSTATION Wirelessly Transfer Images Directly to PACS, Ultra-light, and Portable, Design tested to handle, water, dust, and splash resistance The DELWORKS FIT portable tablet workstation aims to maximize the portability and efficiency of the DELWORKS software - utilizing it anytime, anywhere.
Del Medical, Inc.
3.0
In Commercial Distribution

  • 00858340006097 ()


  • Diagnostic x-ray digital imaging system workstation
7 lead ECG patient cable to be used with the Chroma device.
SCOTTCARE CORPORATION, THE
100608
In Commercial Distribution

  • 00856298006312 ()


  • Electrocardiographic ambulatory recorder
5 lead ECG patient cable to be used with the Chroma device.
SCOTTCARE CORPORATION, THE
100605
In Commercial Distribution

  • 00856298006220 ()


  • Electrocardiographic ambulatory recorder
No Description
SCOTTCARE CORPORATION, THE
RZ153C2
In Commercial Distribution

  • 00856298006015 ()
101942

  • Electrocardiographic ambulatory recorder
SUM 8ch radial w/balloon,
Covidien LP
9012P1422
Not in Commercial Distribution

  • 05704736001328 ()
  • 10884521742826 ()
9012P1422

  • Manometric gastrointestinal motility analysis system
8ch Anorectal SUM 0,0.5
Covidien LP
9012P1412
Not in Commercial Distribution

  • 05704736001311 ()
  • 10884521742710 ()
9012P1412

  • Manometric gastrointestinal motility analysis system
4 ch Anorectal Cat. Sil. w/Bal,
Covidien LP
9012P1392
Not in Commercial Distribution

  • 05704736001304 ()
  • 10884521742703 ()
9012P1392

  • Manometric gastrointestinal motility analysis system
Single use Catheter 4 ch w/o central lum
Covidien LP
9012P1362
Not in Commercial Distribution

  • 05704736001298 ()
  • 10884521742819 ()
9012P1362

  • Manometric gastrointestinal motility analysis system
4ch 7.5mm sp Esophageal
Covidien LP
9012P1352
Not in Commercial Distribution

  • 05704736001281 ()
  • 10884521742802 ()
9012P1352

  • Manometric gastrointestinal motility analysis system
8ch Anorectal SinUse Man,
Covidien LP
9012P1322
Not in Commercial Distribution

  • 05704736001274 ()
  • 10884521742796 ()
9012P1322

  • Manometric gastrointestinal motility analysis system
8ch Vector Vol. SinUse Man
Covidien LP
9012P1312
Not in Commercial Distribution

  • 05704736001267 ()
  • 10884521742789 ()
9012P1312

  • Manometric gastrointestinal motility analysis system
4ch Anorectal SinUse Man.cath,0,1,2,3-ba
Covidien LP
9012P1302
Not in Commercial Distribution

  • 05704736001250 ()
  • 10884521742772 ()
9012P1302

  • Manometric gastrointestinal motility analysis system
8ch Esophageal Sinuse Ma,
Covidien LP
9012P1212
Not in Commercial Distribution

  • 05704736001243 ()
  • 10884521742758 ()
9012P1212

  • Manometric gastrointestinal motility analysis system
8ch Esophageal Sinuse Ma,
Covidien LP
9012P1222
Not in Commercial Distribution

  • 05704736001236 ()
  • 10884521742765 ()


  • Manometric gastrointestinal motility analysis system
Esophageal SinUse Man. Cath.,0,5,10,15 c
Covidien LP
9012P1202
Not in Commercial Distribution

  • 05704736001229 ()
  • 15704736001226 ()


  • Manometric gastrointestinal motility analysis system
FLIP Topography Module
Covidien LP
DD-961
In Commercial Distribution

  • 05391530810142 ()


  • Manometric gastrointestinal motility analysis system
No Description
IRHYTHM TECHNOLOGIES, INC.
DFG0001
In Commercial Distribution

  • 00869770000241 ()


  • Electrocardiographic ambulatory recorder
ZIO SR ECG Monitoring Service
IRHYTHM TECHNOLOGIES, INC.
K100A101X
Not in Commercial Distribution

  • 00869770000234 ()


  • Electrocardiographic ambulatory recorder
ZIO AT ECG Monitoring Service
IRHYTHM TECHNOLOGIES, INC.
A100A100X
In Commercial Distribution

  • 00869770000210 ()


  • Electrocardiographic ambulatory recorder
ZIO XT ECG Monitoring Service
IRHYTHM TECHNOLOGIES, INC.
N100A102X
In Commercial Distribution

  • 00869770000203 ()


  • Electrocardiographic ambulatory recorder
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