The Surgical Company International B.V.

The Surgical Company International B.V.

Address:Bedrijvenpark Twente Noord 48,Almelo Overijssel,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

No

Clear

Mistral-Air - 18719867000038 Catalog Number :

Device Description : Mistral-Air® Plus Warming Unit - SYK (110-120V)

Device Class : 2

Duns Number: 409656493

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Mistral-Air - 18719867000069 Catalog Number :

Device Description : Mistral-Air® Warming Unit - SYK

Device Class : 2

Duns Number: 409656493

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Mistral-Air - 18719867000229 Catalog Number :

Device Description : Mistral-Air® Tube - SYK

Device Class : 2

Duns Number: 409656493

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Mistral-Air - 18719867000427 Catalog Number :

Device Description : Mistral-Air® Warming Suit, S – SYK

Device Class : 2

Duns Number: 409656493

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Mistral-Air - 18719867000465 Catalog Number :

Device Description : Mistral-Air® Warming Suit, M/L - SYK

Device Class : 2

Duns Number: 409656493

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Mistral-Air - 18719867000526 Catalog Number :

Device Description : Mistral-Air® Warming Suit, XL - SYK

Device Class : 2

Duns Number: 409656493

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Mistral-Air - 18719867000564 Catalog Number :

Device Description : Mistral-Air® Adult Plus – SYK

Device Class : 2

Duns Number: 409656493

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Mistral-Air - 18719867000601 Catalog Number :

Device Description : Mistral-Air® Paediatric Plus – SYK

Device Class : 2

Duns Number: 409656493

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Mistral-Air - 18719867000649 Catalog Number :

Device Description : Mistral-Air® Neonatal Plus – SYK

Device Class : 2

Duns Number: 409656493

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Mistral-Air - 18719867000687 Catalog Number :

Device Description : Mistral-Air® Lower Body Plus – SYK

Device Class : 2

Duns Number: 409656493

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

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