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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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
Parallel pin Long
DENTIN IMPLANTS TECHNOLOGIES LTD
DCT-L400
In Commercial Distribution

  • 07290113356184 ()


  • Dental implant/prosthesis surgical procedure kit
Parallel pin Short
DENTIN IMPLANTS TECHNOLOGIES LTD
DCT-0400
In Commercial Distribution

  • 07290113356177 ()


  • Dental implant/prosthesis surgical procedure kit
NOVA Software
DIOPSYS, INC.
NOVA 2.19
In Commercial Distribution

  • 00850514007091 ()


  • Vision electrophysiology analysis system
Medical Software
HILL-ROM, INC.
1.6
In Commercial Distribution

  • 00887761001572 ()


  • Obstetrics information system application software
PACS Scan Software
HYLAND LLC
5
In Commercial Distribution

  • 00850677007006 ()


  • Radiography digital imaging scanner
CART FOR EEG-9200 / EEG-1200
NIHON KOHDEN AMERICA, INC.
A/SONYCART-3
In Commercial Distribution

  • 00841983103766 ()
A/SONYCART-3

  • Instrument trolley
CART FOR EEG-9200 / EEG-1200
NIHON KOHDEN AMERICA, INC.
A/SONYCART
In Commercial Distribution

  • 00841983103759 ()
A/SONYCART

  • Instrument trolley
CART FOR EEG-9200 / EEG-1200
NIHON KOHDEN AMERICA, INC.
A/NIH8000
In Commercial Distribution

  • 00841983103704 ()
A/NIH8000

  • Instrument trolley
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