FDA.reportPublic FDA data

BoneFoam

Primary DI
00810075280050
Brand
BoneFoam
Company
BONE FOAM, INC.
Model
10-910-07-C
Catalog number
10-910-07-C
Device description
Troop Arm Board Pad Set of 2
Published
2022-05-22
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810075280050PrimaryGS10
00810075281019Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810075280050008100752800508100752800500810075280050
00810075281019008100752810198100752810190810075281019

GMDN Terms#

Term, Definition table
TermDefinition
Operating table patient positioning set, reusableA collection of devices intended to support and stabilize in a desired position a patient, or their body parts, on an operating table during a medical procedure (e.g., bariatric surgery, orthopaedic surgery, endotracheal tube intubation); some types may be intended to prevent a patient from sliding while in the Trendelenburg position or when applying traction. The set consists of multiple items which include two or more of the following: a base plate/bar that serves as a foundation to which patient positioners are attached, clamps/adaptors, and disposable/reusable padded positioners dedicated to a body part (e.g., non-slip positioning pad, headrest). This is a reusable device.

Regulatory Flags#

DUNS number
079636174
Device count
2
Premarket exempt
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
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
00810075280661BoneFoam925.ERLE-R-BX3925.ERLE-R-BX32022-05-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
07613327632859SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327632866SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
10197344149834MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-22
10197344149803MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
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G242SS01DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS04DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS05DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS08DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
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G242SS11DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS15DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
10197344161034MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-07-28
10197344158768MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-06-30
10197344100392MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-04-05
10080196413805MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-01-22