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

  • 07290114064071 ()
407-000024-00

  • Brain-responsive electrical stimulation system
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
No Description
Philips Medical Systems Hsg
Philips Holter Software
In Commercial Distribution

  • 00884838000469 ()
860292

  • Electrocardiographic ambulatory recorder
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 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 primary packaging (x1)
Endo Tools Therapeutics
endomina platform
In Commercial Distribution

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


  • Endoscopic overtube, single-use
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
The TrueLabor's Monitor Adapter for the hospital maternal/fetal monitoring system. The corresponding Maternal Unit transmits the uterine activity/fetal heart rate information via Bluetooth to the MONITOR ADAPTER which transfers it to the hospital monitor or directly to the hospital IT system.
O.B - TOOLS LTD
FG0002(X)
In Commercial Distribution

  • 07290016406023 ()

  • Depth: 30 Millimeter
  • Width: 200 Millimeter
  • Height: 120 Millimeter
  • Weight: 400 Gram
FG0002(X)

  • Cardiotocography telemetric monitoring system
TrueLabor's Maternal Unit is connected via a proprietary connector to the Embrace electrode array. The MU acquires EMG signals and provides Fetal Heart Rate and Uterine Activity are transmitted via Bluetooth. The unit contains a Li-Ion rechargeable battery.
O.B - TOOLS LTD
FG0001(X)
In Commercial Distribution

  • 07290016406016 ()

  • Width: 90 Millimeter
  • Height: 125 Millimeter
  • Depth: 29 Millimeter
  • Weight: 240 Gram
FG0001(X)

  • Cardiotocography telemetric monitoring system
ZephyrLIFE Hospital Application Software Application?
ZEPHYR TECHNOLOGY LLC
Software Hospital
Not in Commercial Distribution

  • 10884521712904 ()
Software Hospital

  • Electrosurgical return electrode, single-use
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