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) (7) Support, head, surgical, ENT (EPW) (6) Drape, surgical, exempt (PUI) (4)

Premarket Exempt

Yes

Clear

Bone Foam - 00810075280005 Catalog Number : 10-910-00

Device Description : Troop Elevation Pillow (Foam) - Disposable (with Barrier Cover & Head Cradle) Box of 3

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : CCX, EPW, PUI

Prescription Use : No

Device Count : 3

Bone Foam - 00810075280012 Catalog Number : 10-911-06-C

Device Description : Troop Elevation Pillow - Coated

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Bone Foam - 00810075280029 Catalog Number : 10-911-07-C

Device Description : Troop Elevation Pillow Addition - Coated

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Bone Foam - 00810075280036 Catalog Number : 10-910-02-C

Device Description : Head Cradle - Coated - Box of 4

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : EPW

Prescription Use : No

Device Count : 4

Bone Foam - 00810075280043 Catalog Number : 10-910-02

Device Description : Head Cradle - Disposable - Box of 4

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : EPW

Prescription Use : No

Device Count : 4

Bone Foam - 00810075280050 Catalog Number : 10-910-07-C

Device Description : Arm Board Pad - Coated - Set of 2

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 2

Bone Foam - 00810075280067 Catalog Number : 10-910-03

Device Description : Disposable Barrier Cover - Box of 30

Device Class : 2

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 30

Bone Foam - 00810075280074 Catalog Number : 10-910-06-C

Device Description : Troop Elevation Pillow - Complete System (includes Troop Elevation Pillow - Coat Troop Elevation Pillow - Complete System (includes Troop Elevation Pillow - Coated, Troop Elevation Pillow Addition - Coated, Head Cradle - Coated, Arm Board Pads - Coated, Single Use Disposable Barrier Covers)

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : PUI, CCX, EPW

Prescription Use : No

Device Count : 1

Bone Foam - 00810075280081 Catalog Number : 10-910-01-C

Device Description : Troop Elevation Pillow - Standard System (includes Troop Elevation Pillow - Coat Troop Elevation Pillow - Standard System (includes Troop Elevation Pillow - Coated, Head Cradle - Coated, Arm Board Pads - Coated, Disposable Barrier Covers)

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : CCX, EPW, PUI

Prescription Use : No

Device Count : 1

Bone Foam - 00810075280098 Catalog Number : 10-910-12-C-I

Device Description : Troop Elevation Pillow - Coated (2-set) (includes Troop Elevation Pillow - Coate Troop Elevation Pillow - Coated (2-set) (includes Troop Elevation Pillow - Coated, Head Cradle - Coated)

Device Class : 1

Duns Number: 079636174

Premarket Exempt : Yes

Product Code : CCX, EPW

Prescription Use : No

Device Count : 1

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