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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 Full Underbody - SYK
The Surgical Company International B.V.
MA3400-PM
In Commercial Distribution

  • ET37MA3400PM0 ()
  • ET37MA3400PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Premium Half Upper Body - SYK
The Surgical Company International B.V.
MA3365-PM
In Commercial Distribution

  • ET37MA3365PM1 ()
  • ET37MA3365PM0 ()


  • External circulating-air core temperature regulation system pad, single-use
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® Premium Adult - SYK
The Surgical Company International B.V.
MA3320-PM
In Commercial Distribution

  • ET37MA3320PM1 ()
  • ET37MA3320PM0 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Paediatric Underbody Plus - SYK
The Surgical Company International B.V.
MA2475-PM
In Commercial Distribution

  • ET37MA2475PM0 ()
  • ET37MA2475PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Half Underbody Plus – SYK
The Surgical Company International B.V.
MA2450-PM
In Commercial Distribution

  • ET37MA2450PM0 ()
  • ET37MA2450PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Full Underbody Plus – SYK
The Surgical Company International B.V.
MA2400-PM
In Commercial Distribution

  • ET37MA2400PM0 ()
  • ET37MA2400PM1 ()


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