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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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Mistral-Air® Premium Upper Body - SYK
The Surgical Company International B.V.
MA3360-PM
In Commercial Distribution

  • ET37MA3360PM1 ()
  • ET37MA3360PM0 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Premium Lower Body - SYK
The Surgical Company International B.V.
MA3350-PM
In Commercial Distribution

  • ET37MA3350PM1 ()
  • ET37MA3350PM0 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Premium Neonatal - SYK
The Surgical Company International B.V.
MA3340-PM
In Commercial Distribution

  • ET37MA3340PM1 ()
  • ET37MA3340PM0 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Premium Paediatric - SYK
The Surgical Company International B.V.
MA3330-PM
In Commercial Distribution

  • ET37MA3330PM1 ()
  • ET37MA3330PM0 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air Blanket, Cardiac Blanket Plus (sterile) - SYK
The Surgical Company International B.V.
MA2286-PM
In Commercial Distribution

  • ET37MA2286PM0 ()
  • ET37MA2286PM1 ()


  • Circulating-air whole-body heating/cooling system pad, single-use, sterile
Mistral-Air Blanket, Lower Surgical Access Plus (sterile) - SYK
The Surgical Company International B.V.
MA2285-PM
In Commercial Distribution

  • ET37MA2285PM0 ()
  • ET37MA2285PM1 ()


  • Circulating-air whole-body heating/cooling system pad, single-use, sterile
Mistral-Air® Torso Plus - SYK
The Surgical Company International B.V.
MA2270-PM
In Commercial Distribution

  • ET37MA2270PM0 ()
  • ET37MA2270PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Upper Body Plus – SYK
The Surgical Company International B.V.
MA2260-PM
In Commercial Distribution

  • ET37MA2260PM0 ()
  • ET37MA2260PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Neonatal Plus – SYK
The Surgical Company International B.V.
MA2240-PM
In Commercial Distribution

  • ET37MA2240PM0 ()
  • ET37MA2240PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Adult Plus – SYK
The Surgical Company International B.V.
MA2220-PM
In Commercial Distribution

  • ET37MA2220PM0 ()
  • ET37MA2220PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
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