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) Support, head, surgical, ENT (EPW) (1)

Premarket Exempt

Yes

Clear

Bone Foam - 00810075280104 Catalog Number : 10-910-13-C-I

Device Description : Troop Elevation Pillow - Coated (3-set) (includes Troop Elevation Pillow - Coate Troop Elevation Pillow - Coated (3-set) (includes Troop Elevation Pillow - Coated, Troop Elevation Pillow Addition - Coated, Head Cradle - Coated)

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : EPW, CCX

Prescription Use : No

Device Count : 1

Bone Foam - 00810075280111 Catalog Number : 925.MBS

Device Description : Tray Topper Small (Fits standard Mayo Stand 12-13 Inch x 19-19.625 Inch)

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Bone Foam - 00810075280128 Catalog Number : 925.MBR

Device Description : Tray Topper Regular (Fits standard Mayo Stand 17 Inch x 21.75 Inch)

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Bone Foam - 00810075280135 Catalog Number : 925.MBL

Device Description : Tray Topper Large (Fits Large Mayo Stand 20 Inch x 25 Inch)

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Bone Foam - 00810075280142 Catalog Number : 925.TR

Device Description : The Ramp (Leg Elevator)

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Bone Foam - 00810075280159 Catalog Number : 925.TRS

Device Description : The Ramp Shorty (Leg Elevator)

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Bone Foam - 00810075280166 Catalog Number : 925.PTR

Device Description : Pediatric Ramp (Leg Elevator)

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Bone Foam - 00810075280173 Catalog Number : 925.SCTR

Device Description : Surgery Center Ramp (Leg Elevator)

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Bone Foam - 00810075280180 Catalog Number : 925.PSCTR

Device Description : Surgery Center Pediatric Ramp

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Bone Foam - 00810075280197 Catalog Number : 925.SER

Device Description : Semi-Extended Ramp

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

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