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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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5% NAF VARNISH MELON 200BX
DEN-MAT HOLDINGS, LLC
VN200ML
In Commercial Distribution

  • D813VN200ML1 ()
  • D813VN200ML0 ()
VN200ML

  • Dental coating, tooth-desensitizing
5% NAF VARNISH BBLGUM 200BX
DEN-MAT HOLDINGS, LLC
VN200BG
In Commercial Distribution

  • D813VN200BG1 ()
  • D813VN200BG0 ()
VN200BG

  • Dental coating, tooth-desensitizing
5% NAF VARNISH MINT 35BX
DEN-MAT HOLDINGS, LLC
VN035MT
In Commercial Distribution

  • D813VN035MT1 ()
  • D813VN035MT0 ()
VN035MT

  • Dental coating, tooth-desensitizing
5% NAF VARNISH MELON 35BX
DEN-MAT HOLDINGS, LLC
VN035ML
In Commercial Distribution

  • D813VN035ML1 ()
  • D813VN035ML0 ()
VN035ML

  • Dental coating, tooth-desensitizing
5% NAF VARNISH BBLGUM 35BX
DEN-MAT HOLDINGS, LLC
VN035BG
In Commercial Distribution

  • D813VN035BG1 ()
  • D813VN035BG0 ()
VN035BG

  • Dental coating, tooth-desensitizing
Wick with 80cc Collection Bag
Beaver-Visitec International, Inc.
NS40430
In Commercial Distribution

  • 30886158012161 ()
  • 00886158012160 ()


  • Surgical tissue/fluid collection bag, non-sterile
Wick with 80cc Collection Bag
Beaver-Visitec International, Inc.
400108B
In Commercial Distribution

  • 30886158011010 ()
  • 00886158011019 ()


  • Surgical tissue/fluid collection bag, non-sterile
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
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