BONE FOAM, INC.

Address:20175 County Road 50,Corcoran,MN,55340,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

Clear

Bone Foam - 00810075280203 Catalog Number : 925.TRPP2

Device Description : The Ramp Prone Positioner 2

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Bone Foam - 00810075280210 Catalog Number : 925.SHARK-WS

Device Description : The Shark with Straps

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Bone Foam - 00810075280227 Catalog Number : 925.SHARK-S-WS

Device Description : The Shark Small with Straps

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Bone Foam - 00810075280234 Catalog Number : 925.RLT2-WS

Device Description : Right Leg Tunnel with Straps

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Bone Foam - 00810075280241 Catalog Number : 925.LLT2-WS

Device Description : Left Leg Tunnel with Straps

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Bone Foam - 00810075280258 Catalog Number : 925.ULT2-WS

Device Description : Universal Leg Tunnel with Straps

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Bone Foam - 00810075280265 Catalog Number : 925.PULT2-WS

Device Description : Pediatric Leg Tunnel with Straps

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Bone Foam - 00810075280272 Catalog Number : 925.9CB

Device Description : 9Inch Cylindrical Bump

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Bone Foam - 00810075280289 Catalog Number : 925.7CB

Device Description : 7Inch Cylindrical Bump

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Bone Foam - 00810075280296 Catalog Number : 925.5CB

Device Description : 5Inch Cylindrical Bump

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

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