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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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DelWorks - 00858340006097

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

Chroma 7 Lead Patient Cable - 00856298006312

7 lead ECG patient cable to be used with the Chroma device.
SCOTTCARE CORPORATION, THE
100608
In Commercial Distribution

  • 00856298006312 ()


  • Electrocardiographic ambulatory recorder

Chroma 5 Lead Patient Cable - 00856298006220

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

  • 00856298006220 ()


  • Electrocardiographic ambulatory recorder

Chroma2 - 00856298006015

No Description
SCOTTCARE CORPORATION, THE
RZ153C2
In Commercial Distribution

  • 00856298006015 ()
101942

  • Electrocardiographic ambulatory recorder

ManoScan - 05704736001328

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

  • 05704736001328 ()
  • 10884521742826 ()
9012P1422

  • Manometric gastrointestinal motility analysis system

ManoScan - 05704736001311

8ch Anorectal SUM 0,0.5
Covidien LP
9012P1412
Not in Commercial Distribution

  • 05704736001311 ()
  • 10884521742710 ()
9012P1412

  • Manometric gastrointestinal motility analysis system

ManoScan - 05704736001304

4 ch Anorectal Cat. Sil. w/Bal,
Covidien LP
9012P1392
Not in Commercial Distribution

  • 05704736001304 ()
  • 10884521742703 ()
9012P1392

  • Manometric gastrointestinal motility analysis system

ManoScan - 05704736001298

Single use Catheter 4 ch w/o central lum
Covidien LP
9012P1362
Not in Commercial Distribution

  • 05704736001298 ()
  • 10884521742819 ()
9012P1362

  • Manometric gastrointestinal motility analysis system

ManoScan - 05704736001281

4ch 7.5mm sp Esophageal
Covidien LP
9012P1352
Not in Commercial Distribution

  • 05704736001281 ()
  • 10884521742802 ()
9012P1352

  • Manometric gastrointestinal motility analysis system

ManoScan - 05704736001274

8ch Anorectal SinUse Man,
Covidien LP
9012P1322
Not in Commercial Distribution

  • 05704736001274 ()
  • 10884521742796 ()
9012P1322

  • Manometric gastrointestinal motility analysis system
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