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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 Warming Suit, Medium - SYK
The Surgical Company International B.V.
MA1620-PM
In Commercial Distribution

  • ET37MA1620PM0 ()
  • ET37MA1620PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Premium Warming Suit, Small - SYK
The Surgical Company International B.V.
MA1610-PM
In Commercial Distribution

  • ET37MA1610PM0 ()
  • ET37MA1610PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Tube - SYK
The Surgical Company International B.V.
MA0510-PM
In Commercial Distribution

  • ET37MA0510PM0 ()
  • ET37MA0510PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Underbody Reflective - SYK
The Surgical Company International B.V.
MA0450-PM
In Commercial Distribution

  • ET37MA0450PM0 ()
  • ET37MA0450PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Full Underbody Reflective - SYK
The Surgical Company International B.V.
MA0400-PM
In Commercial Distribution

  • ET37MA0400PM0 ()
  • ET37MA0400PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Half Upper Body Reflective - SYK
The Surgical Company International B.V.
MA0365-PM
In Commercial Distribution

  • ET37MA0365PM0 ()
  • ET37MA0365PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Upper Body Reflective - SYK
The Surgical Company International B.V.
MA0360-PM
In Commercial Distribution

  • ET37MA0360PM0 ()
  • ET37MA0360PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Lower Body Reflective - SYK
The Surgical Company International B.V.
MA0350-PM
In Commercial Distribution

  • ET37MA0350PM0 ()
  • ET37MA0350PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Neonatal Reflective - SYK
The Surgical Company International B.V.
MA0340-PM
In Commercial Distribution

  • ET37MA0340PM0 ()
  • ET37MA0340PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Paediatric Reflective - SYK
The Surgical Company International B.V.
MA0330-PM
In Commercial Distribution

  • ET37MA0330PM0 ()
  • ET37MA0330PM1 ()


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