FDA.reportPublic FDA data

BoneFoam

Primary DI
00810075281415
Brand
BoneFoam
Company
BONE FOAM, INC.
Model
925.HIPPY-DBC-BX20
Catalog number
925.HIPPY-DBC-BX20
Device description
Direct Anterior Hip Positioning System - Disposable Barrier Cover - Box of 20
Published
2024-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KMEBedding, Disposable, Medical
PUIDrape, Surgical, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810075281408PrimaryGS10
00810075281415Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810075281408008100752814088100752814080810075281408
00810075281415008100752814158100752814150810075281415

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079636174
Device count
20
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00618125192502Ziehm ImagingTIDI PRODUCTS, LLCPUI2026-10-22
08684382977444SUBMEDSU BIYOMEDIKAL SISTEMLER VE SAGLIK HIZMETLERI SANAYI VE TICARET ANONIM SIRKETIPUI2026-10-20
08684382977451SUBMEDSU BIYOMEDIKAL SISTEMLER VE SAGLIK HIZMETLERI SANAYI VE TICARET ANONIM SIRKETIPUI2026-10-20
08684382999712SUBMEDSU BIYOMEDIKAL SISTEMLER VE SAGLIK HIZMETLERI SANAYI VE TICARET ANONIM SIRKETIPUI2026-10-20
00850086479296ValmaxSupply Line MedicalKME2026-10-19
00850067913238SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913245SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913252SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913269SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913276SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913283SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913085SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913092SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913108SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913115SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913122SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913139SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913146SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913153SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913160SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913191SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913214SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913221SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00748426264575Medline-MicrotekMicrotek Medical LLCPUI2026-10-14
10192253072211CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072228CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072235CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072242CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072259CONVERTORSCardinal Health 200, LLCPUI2026-10-14
20193489029946MedlineMEDLINE INDUSTRIES, INC.PUI2026-10-14