SOULE CO., THE

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 - 00810082220001 Catalog Number : HR101

Device Description : Head Cradle Positioner

Device Class :

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082220018 Catalog Number : BBP1020

Device Description : Bean Bag Positioner (10X20)

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082220025 Catalog Number : ABS01

Device Description : Armboard Strap - 2" x 22"

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082220070 Catalog Number : RG0100-24505

Device Description : Gel Pad - 24" x 50" x .5"

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082220094 Catalog Number : RG2100

Device Description : Gel 3/4 table pad - 46"L x 20"W x .5"H

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082220100 Catalog Number : RG2110

Device Description : Gel Full table pad - 72"L x 20"W x .5"H

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082220117 Catalog Number : RG2110-25

Device Description : Gel Full table pad lightweight - 72"L x 20"W x .25"H

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082220124 Catalog Number : RG2120

Device Description : Gel 3/4 table pad w/ GU cutout - 46"L x 20"W x .5"H

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082220131 Catalog Number : RG2130

Device Description : Gel 3 piece table pad (2 GU cutouts) - (see RG2130-1, RG2130-2 & RG2130-3)

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082220209 Catalog Number : RG2150

Device Description : Gel Adult head donut - 8"OD x 3"ID x 1.75"H

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

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