FDA.report

Bone Foam, Inc.

Primary DI
B197925SBCB1
Brand
Bone Foam, Inc.
Company
BONE FOAM, INC.
Model
925.SBCB
Catalog number
925.SBCB
Device description
sterile bags
Published
2016-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KKXDrape, Surgical
PUIDrape, Surgical, Exempt

Product Code Classifications

CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B197925SBCB1PackageHIBCC25In Commercial Distribution
B197925SBCB0PrimaryHIBCC0

GMDN Terms

TermDefinition
Instrument/equipment drape, single-use, sterileA sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
7635591830sales@bonefoam.com

Regulatory Flags

DUNS number
079636174
Device count
1
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
true
Expiration date on label
true
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 DIBrandModelCatalogPublished
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
00810075281477BoneFoam104.LHS-BX10104.LHS-BX102024-09-09
00810075281446BoneFoam925.PC925.PC2024-07-19
00810075281453BoneFoam925.PC-DBC-BX20925.PC-DBC-BX202024-07-19
00810075281415BoneFoam925.HIPPY-DBC-BX20925.HIPPY-DBC-BX202024-05-22
00810075281439BoneFoam925.ZDK-MUSC-BX12925.ZDK-MUSC-BX122024-05-09
00810075281392BoneFoam925.ZDK-TDG-BX12925.ZDK-TDG-BX122023-11-17
00810075281361BoneFoam925.MTO-C925.MTO-C2023-10-16
00810075281378BoneFoam925.MTO-D925.MTO-D2023-10-16
00810075281323BoneFoam925.UPS-DBC-BX20925.UPS-DBC-BX202022-12-19
00810075281279Bone Foam925.UPS-R-UB925.UPS-R-UB2022-11-21
00810075281286Bone Foam925.UPS-R-LB925.UPS-R-LB2022-11-21
00810075281293Bone Foam925.UPS-S-UB925.UPS-S-UB2022-11-21
00810075281309Bone Foam925.UPS-S-LB925.UPS-S-LB2022-11-21
00810075281347Bone Foam925.UPS-R925.UPS-R2022-11-21

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