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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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Diode (portable)
LIGHT INSTRUMENTS LTD
1
In Commercial Distribution

  • 07290016784039 ()
LI-FGD001(X)

  • Dental solid-state laser system
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
No Description
AXELGAARD MANUFACTURING CO., LTD.
USX2040-4
Not in Commercial Distribution

  • 00856817005871 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable
No Description
AXELGAARD MANUFACTURING CO., LTD.
USX2040
In Commercial Distribution

  • 00856817005833 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable
No Description
AXELGAARD MANUFACTURING CO., LTD.
USX2020
In Commercial Distribution

  • 00856817005826 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable
No Description
AXELGAARD MANUFACTURING CO., LTD.
USX2000
In Commercial Distribution

  • 00856817005819 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable
Robotic Exoscope
Synaptive Medical Inc
SYN-0974
In Commercial Distribution

  • 00670082000573 ()


  • General-purpose surgical microscope
Robotic Exoscope
Synaptive Medical Inc
SYN-0976
In Commercial Distribution

  • 00670082000566 ()


  • General-purpose surgical microscope
NexPak X Intranasal Splint is a sterile flexible foam pad comprised of a lyophilized mixture of starch polysaccharide and polysaccharide binders. NexPak X Intranasal Splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and nasal cavity. The intranasal splint is placed in the nasal cavity after surgery or trauma.
HEMOSTASIS, LLC
9110534
In Commercial Distribution

  • 00858439001644 ()
  • 00858439001637 ()

  • Length: 2.0 Inch
  • Width: 0.6 Inch


  • Intranasal splint, non-biodegradable
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