FDA.reportPublic FDA data

BoneFoam

Primary DI
00810075281354
Brand
BoneFoam
Company
BONE FOAM, INC.
Model
925.UPS-S
Catalog number
925.UPS-S
Device description
Universal Prone Small
Published
2022-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CCXSUPPORT, PATIENT POSITION
PUIDrape, Surgical, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810075281354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810075281354008100752813548100752813540810075281354

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding patient positioner, reusableA 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 reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length33.5Inch
Width17Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079636174
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00810075281590BoneFoam925.SG-BX10925.SG-BX102025-08-15
00810075281613BoneFoam925.ZDK-DOC-BX12925.ZDK-DOC-BX122025-08-15
00810075280005BoneFoam10-910-0010-910-002022-05-22
00810075280036BoneFoam10-910-02-C10-910-02-C2022-05-22
00810075280043BoneFoam10-910-0210-910-022022-05-22
00810075280050BoneFoam10-910-07-C10-910-07-C2022-05-22
00810075280524BoneFoam925.PROP-R-BX5925.PROP-R-BX52022-05-22
00810075280531BoneFoam925.PROP-L-BX5925.PROP-L-BX52022-05-22
00810075280593BoneFoam925.PF-SSP-BX6925.PF-SSP-BX62022-05-22
00810075280616BoneFoam925.ZDK-BX12925.ZDK-BX122022-05-22
00810075280623BoneFoam925.ZDK-AveraMarshall-BX12925.ZDK-AveraMarshall-BX122022-05-22
00810075280630BoneFoam925.ZDK-AveraMcKennan-BX12925.ZDK-AveraMcKennan-BX122022-05-22
00810075280647BoneFoam925.ZDK-Mansfield-BX12925.ZDK-Mansfield-BX122022-05-22

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