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 - 00810082221206 Catalog Number : SRLE-CC

Device Description : Leg Ramp Elevator - Coated Cover

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082221213 Catalog Number : SRLE-CC

Device Description : Leg Ramp Elevator - Coated Cover

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082221220 Catalog Number : SRLE-PP-CC

Device Description : Ramp/Leg Elevator (Pediatric)-Coated Cover

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082221237 Catalog Number : SRLE-PP-CC-4

Device Description : 4" Ramp/Leg Elevator (Pediatric)-Coated Cover

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082221244 Catalog Number : SRLT-CC

Device Description : Leg Tunnel (Right)- Coated Cover

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082221251 Catalog Number : SRPP-CC

Device Description : Prone Positioning Wedge- Coated Cover

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082221268 Catalog Number : SRUEWL-CC

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

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082221275 Catalog Number : SRUEWS-CC

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

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082221282 Catalog Number : SUEB-L-CC

Device Description : Upper Extremity Block-Large - Coated Cover

Device Class : 1

Duns Number: 032801706

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Soule Medical - 00810082221299 Catalog Number : SUEB-S-CC

Device Description : Upper Extremity Block-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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