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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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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
BioWick X 6.5mm Pre-Loaded Implant
CAYENNE MEDICAL, INC.
CM-6265
In Commercial Distribution

  • M543CM6265 ()


  • Orthopaedic bone screw, non-bioabsorbable, sterile
  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
BioWick X 5.5mm Pre-Loaded Implant
CAYENNE MEDICAL, INC.
CM-6255
In Commercial Distribution

  • M543CM6255 ()


  • Orthopaedic bone screw, non-bioabsorbable, sterile
  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Ultrasound Doppler Device (Doppler-Box X1)
Compumedics Germany GmbH
DBX1
In Commercial Distribution

  • 04260493310765 ()
7780

  • Invasive vascular ultrasound system
  • Noninvasive vascular ultrasound system, line-powered
Ultrasound Doppler Device
Compumedics Germany GmbH
DBX
In Commercial Distribution

  • 04260493310055 ()
7750

  • Noninvasive vascular ultrasound system, line-powered
  • Invasive vascular ultrasound system
No Description
NAKANISHI INC.
X-DSG20L
Not in Commercial Distribution

  • 04560264528475 ()
  • 04560264557154 ()


  • Dental power tool system handpiece, line-powered
No Description
NAKANISHI INC.
X-DSG20
Not in Commercial Distribution

  • 04560264528468 ()
  • 04560264557147 ()


  • Dental power tool system handpiece, line-powered
No Description
NAKANISHI INC.
X-SG65L
Not in Commercial Distribution

  • 04560264518575 ()
  • 04560264557291 ()


  • Dental power tool system handpiece, line-powered
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