FDA.reportPublic FDA data

Bone Foam

Primary DI
00810075281026
Brand
Bone Foam
Company
BONE FOAM, INC.
Model
10-910-03
Catalog number
10-910-03
Device description
Disposable Barrier Cover - Box of 30
Published
2022-05-22
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
PUIDrape, surgical, exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810075280067PrimaryGS10
00810075281026Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810075280067008100752800678100752800670810075280067
00810075281026008100752810268100752810260810075281026

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
30
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
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
00810075281590BoneFoam925.SG-BX10925.SG-BX102025-08-15
00810075281613BoneFoam925.ZDK-DOC-BX12925.ZDK-DOC-BX122025-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00748426263448Convertors®Microtek Medical LLCPUI2026-06-09
30680651501272HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501289HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501296HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501302HalyardO&M HALYARD, INC.PUI2026-06-08
16931918100876AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918102450AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104201AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104416AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104645AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104843AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104935AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918105239AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918106977AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918107400AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918107929AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918108261AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918109640AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918109855AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918109879AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918117102AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918139449AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918179179AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
30680651424465HalyardO&M HALYARD, INC.PUI2026-06-02
50192253071595CONVERTORSCardinal Health 200, LLCPUI2026-06-02
50192253071601CONVERTORSCardinal Health 200, LLCPUI2026-06-02
50192253071618CONVERTORSCardinal Health 200, LLCPUI2026-06-02
50192253071625CONVERTORSCardinal Health 200, LLCPUI2026-06-02
00748426121861OLYMPUSMicrotek Medical LLCPUI2026-05-28
07466532979338Moon SurgicalDAS Medical International SRLPUI2026-05-28