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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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tetraONE software - 15099590572679

tetraONE
Beckman Coulter, Inc.
6915050
In Commercial Distribution

  • 15099590572679 ()
6915050

  • Laboratory instrument/analyser application software IVD

StemONE software - 15099590559519

stemONE
Beckman Coulter, Inc.
6915452
In Commercial Distribution

  • 15099590559519 ()
6915452

  • Laboratory instrument/analyser application software IVD

HaGuide Software - 07290114064545

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
HaGuide Software
In Commercial Distribution

  • 07290114064545 ()
407-000024-00

  • Depth electrode

HaGuide Software - 07290114064071

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
HaGuide Software
In Commercial Distribution

  • 07290114064071 ()
407-000024-00

  • Brain-responsive electrical stimulation system

Holter Software - 00884838094895

Philips Holter Software w/ Zymed Alg
Philips Medical Systems Hsg
Philips Holter Software
In Commercial Distribution

  • 00884838094895 ()
860292

  • Electrocardiographic long-term ambulatory recording analyser application software

Holter Software - 00884838000469

No Description
Philips Medical Systems Hsg
Philips Holter Software
In Commercial Distribution

  • 00884838000469 ()
860292

  • Electrocardiographic ambulatory recorder

TAPES - 05425029282094

TAPES primary packaging (x1)
Endo Tools Therapeutics
TAPES
In Commercial Distribution

  • 05425029282698 ()
  • 05425029282094 ()
  • 05425029282391 ()
  • 05425029282995 ()
  • 05425029282919 ()
  • 05425029282988 ()
  • 05425029282933 ()
  • 05425029282964 ()


  • Suturing unit, single-use

endomina system - 05425029282070

endomina system is composed of 1 endomina platform and 6 TAPES
Endo Tools Therapeutics
endomina system
In Commercial Distribution

  • 05425029282070 ()
  • 05425029282971 ()


  • Endoscopic overtube, single-use
  • Suturing unit, single-use

endomina platform - 05425029282018

endomina platform primary packaging (x1)
Endo Tools Therapeutics
endomina platform
In Commercial Distribution

  • 05425029282117 ()
  • 05425029282018 ()
  • 05425029282339 ()
  • 05425029282940 ()
  • 05425029282957 ()
  • 05425029282926 ()


  • Endoscopic overtube, single-use

EmbraceTM Electrodes Array (L) - 07290016406030

Proprietary bio-compatible patch electrode array with nine Ag/AgCl pads lined with hydrogel. Intended to be used with TrueLabor Maternal Unit.
O.B - TOOLS LTD
FG0003(X)
Not in Commercial Distribution

  • 07290016406030 ()
  • 17290016406037 ()
  • 27290016406034 ()

  • Width: 280 Millimeter
  • Length: 320 Millimeter
FG0003(X)

  • Cardiotocography telemetric monitoring system
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