SOULE CO., THE

Address:4322 PET LN.,LUTZ,FL,33559,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

Support, Patient Position (CCX) (10)

Premarket Exempt

No Yes

Clear

Soule Medical - 00810082220216 Catalog Number : RG2150-T

Device Description : Adult head donut Tall - 7.75"OD x 4" x 3" H

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082220278 Catalog Number : RG2175

Device Description : Medium/pediatric horseshoe - 5.5OD" x 2.25"ID x 1.25"H

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082220544 Catalog Number : RG2370

Device Description : Large gel filled sandbag - 14"L x 4.5"W x 2.25"H

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082220810 Catalog Number : RG2630

Device Description : CUSHION SEAT 16X16X.5IN POLYMER GELNONALLEGENIC

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082220841 Catalog Number : RG2655

Device Description : Wilson frame pad set w/ Velcro® pair - 29"L x 10"W x 1"H

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082220896 Catalog Number : RG2810

Device Description : Back pad for frame - 9"L x 11"W x .5"H w/ pocket

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082220964 Catalog Number : HR101-CC

Device Description : Cradle Head Positioner - Coated Cover

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082220971 Catalog Number : HR104-CC

Device Description : Donut Head Rest 9" - Coated Cover

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082220988 Catalog Number : LP100-CC

Device Description : Total Knee/Leg Elevator - Coated Cover

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082220995 Catalog Number : LP200-CC

Device Description : Leg Elevator - Coated Cover

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

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