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

Yes No

Clear

Soule Medical - 00810082222838 Catalog Number : PBBP-14

Device Description : 14" Peg Covers for Peg Board

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082222845 Catalog Number : PBBP-9

Device Description : 9" Peg Covers for Peg Board

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082222852 Catalog Number : PFXH1000

Device Description : Hana/ProFX Style Positioning Kit - 9" Donut Headrest, Arm Board (Set of 2), Armb Hana/ProFX Style Positioning Kit - 9" Donut Headrest, Arm Board (Set of 2), Armboard Straps (Set of 2) , Ball/Joint Cover (Set of 2) Perineal Post Cover

Device Class :

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082222869 Catalog Number : PFXHPPC1000

Device Description : Hana/ProFX Style Positioning Kit - Perineal Post Cover only

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082222876 Catalog Number : PP199

Device Description : Perineal Post Protector

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082222883 Catalog Number : PP7212-78

Device Description : Post Protector

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082222890 Catalog Number : PPK1000

Device Description : Prone Positioning Kit

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082222906 Catalog Number : PU11212

Device Description : Positioning Pad - Foam Pad 12" Length x 12" Width x .12" Height

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082222913 Catalog Number : PU342065

Device Description : Positioning Pad - Foam Pad 20" Length x 6.5" Width x .75" Height

Device Class :

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082222920 Catalog Number : PU3477

Device Description : Positioning Pad - Foam Pad 7" Length x 7" Width x .75" Height

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

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