Medivance, Inc.

Address:321 SOUTH TAYLOR AVENUE,LOUISVILLE,CO,80027,US

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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) (4)

Premarket Exempt

Clear

Arctic Sun® Temperature Management System, Calibration Test Unit - 00801741128967 Catalog Number : 74100L

Device Description : Arctic Sun® Temperature Management System, Calibration Test Unit

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Arctic Sun® Temperature Management System, ArcticGel™ Pads - 00801741132131 Catalog Number : 31802

Device Description : Arctic Sun® Temperature Management System, ArcticGel™ Pads

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Arctic Sun Stat - 00801741161513 Catalog Number : 60000000

Device Description : ARCTIC SUN 6000 115V B PWR

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Arctic Sun Stat - 00801741161520 Catalog Number : 60000000L

Device Description : ARCTIC SUN 6000 115V B PWR LNR

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

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