ADROIT MEDICAL SYSTEMS, INC.

Address:1146 CARDING MACHINE RD.,LOUDON,TN,37774,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

Pack, Hot Or Cold, Water Circulating (ILO) (10)

Premarket Exempt

No Yes

Clear

Soft-Temp - 10615089102100 Catalog Number : ST-021

Device Description : Wrist Pad, Insulated, Velcro Fasteners

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Soft-Temp - 10615089102407 Catalog Number : ST-024

Device Description : Pad Heat Large 18 x 24 in (Filled Dimensions) Non-Woven Fabric Both Sides Latex/ Pad Heat Large 18 x 24 in (Filled Dimensions) Non-Woven Fabric Both Sides Latex/PVC Free Disposable

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Soft-Temp - 10615089102605 Catalog Number : ST-026

Device Description : Leg Pad, Insulated, Velcro Fasteners.

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Soft-Temp - 10615089103008 Catalog Number : ST-030

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Soft-Temp - 10615089103107 Catalog Number : ST-031

Device Description : Leg Wrap

Device Class :

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Soft-Temp - 10615089104005 Catalog Number : ST-040

Device Description : Hyper-Hypothermia Patient Vest.

Device Class :

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Soft-Temp - 10615089104104 Catalog Number : ST-041

Device Description : Arm Pad 8.5 x 9.5 in. Elastic Mesh.

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Soft-Temp - 10615089104302 Catalog Number : ST-043

Device Description : Leg Pad, 12 x 14.5 in. , Elastic Mesh

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Soft-Temp - 10615089104401 Catalog Number : ST-044

Device Description : Patient Vest, Poncho Style, Elastic Straps

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Soft-Temp - 10615089105002 Catalog Number : ST-050

Device Description : Head Wrap

Device Class : 2

Duns Number: 795104769

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

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