The Surgical Company International B.V.

Address:Beeldschermweg 6F,AMERSFOORT Utrecht,NL

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Thermal Regulating (DWJ) (10)

Premarket Exempt

Clear

Mistral-Air - ET37MA02010PM0 Catalog Number :

Device Description : Mistral-Air® Faceshield – SYK

Device Class :

Duns Number: 409656493

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Mistral-Air - ET37MA0320PM0 Catalog Number :

Device Description : Mistral-Air® Adult Reflective - SYK

Device Class :

Duns Number: 409656493

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Mistral-Air - ET37MA0330PM0 Catalog Number :

Device Description : Mistral-Air® Paediatric Reflective - SYK

Device Class :

Duns Number: 409656493

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Mistral-Air - ET37MA0340PM0 Catalog Number :

Device Description : Mistral-Air® Neonatal Reflective - SYK

Device Class :

Duns Number: 409656493

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Mistral-Air - ET37MA0350PM0 Catalog Number :

Device Description : Mistral-Air® Lower Body Reflective - SYK

Device Class :

Duns Number: 409656493

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Mistral-Air - ET37MA0360PM0 Catalog Number :

Device Description : Mistral-Air® Upper Body Reflective - SYK

Device Class :

Duns Number: 409656493

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Mistral-Air - ET37MA0365PM0 Catalog Number :

Device Description : Mistral-Air® Half Upper Body Reflective - SYK

Device Class :

Duns Number: 409656493

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Mistral-Air - ET37MA0400PM0 Catalog Number :

Device Description : Mistral-Air® Full Underbody Reflective - SYK

Device Class :

Duns Number: 409656493

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Mistral-Air - ET37MA0450PM0 Catalog Number :

Device Description : Mistral-Air® Underbody Reflective - SYK

Device Class :

Duns Number: 409656493

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Mistral-Air - ET37MA0510PM0 Catalog Number :

Device Description : Mistral-Air® Tube - SYK

Device Class :

Duns Number: 409656493

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

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