FDA.reportPublic FDA data

BoneFoam

Primary DI
00810075280593
Brand
BoneFoam
Company
BONE FOAM, INC.
Model
925.PF-SSP-BX6
Catalog number
925.PF-SSP-BX6
Device description
Prone One Box of 6
Published
2022-05-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FMPProtector, skin pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810075280593PrimaryGS10
00810075281088Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810075280593008100752805938100752805930810075280593
00810075281088008100752810888100752810880810075281088

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding patient positioner, single-useA preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a single-use device.

Regulatory Flags#

DUNS number
079636174
Device count
6
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810075281675BoneFoam104.UPC-SUK-BX5104.UPC-SUK-BX52026-07-28
00810075281668BoneFoam104.NPC-SUK-BX5104.NPC-SUK-BX52026-06-12
00810075280005BoneFoam10-910-0010-910-002022-05-22
00810075280067BoneFoam10-910-0310-910-032022-05-22
00810075281316BoneFoam925.UPS-DBC-BX20925.UPS-DBC-BX202022-12-19
00810075281279BoneFoam925.UPS-R-UB925.UPS-R-UB2022-11-21
00810075281286BoneFoam925.UPS-R-LB925.UPS-R-LB2022-11-21
00810075281293BoneFoam925.UPS-S-UB925.UPS-S-UB2022-11-21
00810075281309BoneFoam925.UPS-S-LB925.UPS-S-LB2022-11-21
00810075281347BoneFoam925.UPS-R925.UPS-R2022-11-21
00810075281354BoneFoam925.UPS-S925.UPS-S2022-11-21
00810075280074BoneFoam10-910-06-C10-910-06-C2022-05-22
00810075280081BoneFoam10-910-01-C10-910-01-C2022-05-22
00810075281521BoneFoam104.NPL-SUK-BX5104.NPL-SUK-BX52025-08-15
00810075281606BoneFoam925.SG-BX10925.SG-BX102025-08-15
00810075281620BoneFoam925.ZDK-DOC-BX12925.ZDK-DOC-BX122025-08-15
00810075281491BoneFoam104.NPL104.NPL2025-08-15
00810075281507BoneFoam104.NPLB104.NPLB2025-08-15
00810075281514BoneFoam104.NPL-SUK-BX5104.NPL-SUK-BX52025-08-15
00810075281538BoneFoam104.NPSB104.NPSB2025-08-15

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07333350462161Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
07333350529079Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
07333350768249Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
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