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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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Surgical motor system
Nouvag AG
3280
In Commercial Distribution

  • ENOU32800 ()


  • Surgical power tool system control unit, line-powered
Aquasil Ultimate digit power® 15 pk Multi Refill with B4
DENTSPLY INTERNATIONAL INC.
678053K
In Commercial Distribution

  • D002678053K1 ()

  • 15 Digit Power Wash Material Cartridges, 15 Digit Power Mixing Tips with Intraoral Tips, 1 Bottle B4 Pre-Impression Surface Optimizer, 1 Dispensing Well, 25 Flocked Applicator Tips
  • Total Volume: 1.6 Milliliter
  • Total Volume: 6 Milliliter
678053K

  • Silicone dental impression material
Aquasil Ultimate digit power® Single Refill 50 Pack with B4
DENTSPLY INTERNATIONAL INC.
678050K
Not in Commercial Distribution

  • D002678050K1 ()

  • Total Volume: 0.68 Milliliter
  • 50 wash material cartridges, 1 bottle B4, 50 Mixing Tips with Intraoral Tips, 50 Flocked Applicator Tips, 1 Dispensing Well
  • Total Volume: 6 Milliliter
678050K

  • Silicone dental impression material
tomas® anchorage system: tomas®-power arm, round (crimping tube)
DENTAURUM GmbH & Co.KG
302-019-00
In Commercial Distribution

  • J011302019000 ()
  • J011302019001 ()


  • Orthodontic tube
tomas® anchorage system: tomas®-power arm, square (crimping tube)
DENTAURUM GmbH & Co.KG
302-015-00
In Commercial Distribution

  • J011302015000 ()
  • J011302015001 ()


  • Orthodontic tube
6.6F x 750mm Xcela Plastic Power Injectable Port with Silicone Plug
NAVILYST MEDICAL, INC.
H965451250
In Commercial Distribution

  • H965451250 ()
  • 07640110982280 ()

  • Catheter Gauge: 6.6 French
  • Length: 750 Millimeter
  • Needle Gauge: 17 Gauge
  • Outer Diameter: 2.2 Millimeter
  • Lumen/Inner Diameter: 1.3 Millimeter


  • Vascular port/catheter
Refurbished Pump, Battery 1800mAh, Pole Mount Charger, Power Cord, Operator's Manual
CME AMERICA LLC
100-729PXSR
Not in Commercial Distribution

  • B101100729PXSR0 ()


  • Bedside infusion pump, single-channel
Pump, Battery 1800mAh, Bolus Button, Pole-Mount Charger, Power Cord, Operator's Manual
CME AMERICA LLC
100-615PXCVR
Not in Commercial Distribution

  • B101100615PXCVR0 ()


  • Bedside infusion pump, single-channel
Pump, Battery 1800mAh, Bolus Button, Pole-Mount Charger, Power Cord, Operator's Manual
CME AMERICA LLC
100-615PXCV
Not in Commercial Distribution

  • B101100615PXCV0 ()


  • Bedside infusion pump, single-channel
Pump, Battery 1800mAh, Bolus Button, Pole-Mount Charger, Power Cord, Operator's Manual
CME AMERICA LLC
100-610PXCV
Not in Commercial Distribution

  • B101100610PXCV0 ()


  • Bedside infusion pump, single-channel
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