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) (10)

Premarket Exempt

Clear

Arctic Sun® Temperature Management System, ArcticGel™ Pads - 00801741080005 Catalog Number : 31700

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® Temperature Management System, ArcticGel™ Pads - 00801741080029 Catalog Number : 31702

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® Temperature Management System, ArcticGel™ Pads - 00801741080043 Catalog Number : 31703

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® Temperature Management System, ArcticGel™ Pads - 00801741080067 Catalog Number : 31705

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® Temperature Management System, ArcticGel™ Pads - 00801741080081 Catalog Number : 31707

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® Temperature Management System, ArcticGel™ Pads - 00801741080104 Catalog Number : 31709

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® Temperature Management System, ArcticGel™ Pads - 00801741080128 Catalog Number : 31801

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® 5000 - 00801741080142 Catalog Number : 50000000

Device Description : Arctic Sun® 5000

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Arctic Sun® 5000 - 00801741080159 Catalog Number : 50000000L

Device Description : Arctic Sun® 5000

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Arctic Sun® Temperature Management System, Shunt Line - 00801741080173 Catalog Number : 70904

Device Description : Arctic Sun® Temperature Management System, Shunt Line

Device Class : 2

Duns Number: 027183008

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

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