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 - 00810082221107 Catalog Number : SERLE-L-CC

Device Description : Post-Op Leg Elevator (Large) - Coated Cover

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082221114 Catalog Number : SERLE-R-CC

Device Description : Post-Op Leg Elevator (Regular) - Coated Cover

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082221121 Catalog Number : SKB-CC

Device Description : Knee Bolster - Coated Cover

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082221138 Catalog Number : SLLT-CC

Device Description : Leg Tunnel (Left) - Coated Cover

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082221145 Catalog Number : SLUEWL-CC

Device Description : Large Upper Extremity Wedge (Left) - Coated Cover

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082221152 Catalog Number : SLUEWS-CC

Device Description : Small Upper Extremity Wedge (Left)- Coated Cover

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082221169 Catalog Number : SLW-R-CC

Device Description : Lateral Wedge (Regular) - Coated Cover

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082221176 Catalog Number : SLW-S-CC

Device Description : Lateral Wedge (Small) - Coated Cover

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082221183 Catalog Number : SOWL-CC

Device Description : Obtuse Positioning Wedge (Large)- Coated Cover

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082221190 Catalog Number : SOWS-CC

Device Description : Obtuse Positioning Wedge (Small)- Coated Cover

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

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