FDA.reportPublic FDA data

Osteo-P™ Bone Graft Substitute

Primary DI
00811538030144
Brand
Osteo-P™ Bone Graft Substitute
Company
MOLECULAR MATRIX, INC.
Model
BGS-s25x125x5
Catalog number
BGS-s25x125x5
Device description
Osteo-P™ bone graft substitute sheet 25mm x 125mm x 5mm
Published
2023-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811538030144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811538030144008115380301448115380301440811538030144

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic bone graftAn artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
064845937
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811538030113Osteo-P™ Bone Graft Substitute BGS-s25x25x5BGS-s25x25x52023-07-24
00811538030120Osteo-P™ Bone Graft SubstituteBGS-s25x50x5BGS-s25x50x52023-07-24
00811538030137Osteo-P™ Bone Graft SubstituteBGS-s25x75x5BGS-s25x75x52023-07-24
00811538030007Osteo-P™ Bone Graft Substitute BGS-G5BGS-G52018-07-31
00811538030014Osteo-P™ Bone Graft SubstituteBGS-G10BGS-G102018-07-31
00811538030021Osteo-P™ Bone Graft SubstituteBGS-G20BGS-G202018-07-31
00811538030038Osteo-P™ Bone Graft Substitute BGS-G30BGS-G302018-07-31
00811538030045Osteo-P™ Bone Graft Substitute BGS-s25x25x3BGS-s25x25x32018-07-31
00811538030052Osteo-P™ Bone Graft SubstituteBGS-s25x50x3BGS-s25x50x32018-07-31
00811538030069Osteo-P™ Bone Graft SubstituteBGS-b10x6x10BGS-b10x6x102018-07-31
00811538030076Osteo-P™ Bone Graft Substitute BGS-b14x10x14BGS-b14x10x142018-07-31
00811538030083Osteo-P™ Bone Graft SubstituteBGS-s25x75x3BGS-s25x75x32018-07-31
00811538030090Osteo-P™ Bone Graft SubstituteBGS-s25x125x3BGS-s25x125x32018-07-31
00811538030106Osteo-P™ Bone Graft Substitute BGS-CL15x20BGS-CL15x202018-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810131881429OsteoFlo HydroFiber - 1cc LabeledSURGENTEC, LLCMQV2026-03-09
00810131881436OsteoFlo HydroFiber - 3cc LabeledSURGENTEC, LLCMQV2026-03-09
00810131881443OsteoFlo HydroFiber - 6cc LabeledSURGENTEC, LLCMQV2026-03-09
00810131881450OsteoFlo HydroFiber - 12cc LabeledSURGENTEC, LLCMQV2026-03-09
00810131882013Synthetic Fiber Graft - 1ccSURGENTEC, LLCMQV2026-03-09
00810131882020Synthetic Fiber Graft - 3ccSURGENTEC, LLCMQV2026-03-09
00810131882037Synthetic Fiber Graft - 6ccSURGENTEC, LLCMQV2026-03-09
00810131882044Synthetic Fiber Graft - 12ccSURGENTEC, LLCMQV2026-03-09
00810131882136Synthetic Fiber Kit - 1ccSURGENTEC, LLCMQV2026-03-09
00810131882143Synthetic Fiber Kit - 3ccSURGENTEC, LLCMQV2026-03-09
00810131882150Synthetic Fiber Kit - 6ccSURGENTEC, LLCMQV2026-03-09
00810131882167Synthetic Fiber Kit - 12ccSURGENTEC, LLCMQV2026-03-09
00810131883751OsteoFlo Fiber Graft - 1ccSURGENTEC, LLCMQV2026-03-09
00810131883768OsteoFlo Fiber Graft - 3ccSURGENTEC, LLCMQV2026-03-09
00810131883775OsteoFlo Fiber Graft - 6ccSURGENTEC, LLCMQV2026-03-09
00810131883782OsteoFlo Fiber Graft - 12ccSURGENTEC, LLCMQV2026-03-09
00813909013985Putty Syringe with Cannula 2.5ccNOVABONE PRODUCTS, LLCMQV2026-01-28
00813909013992Putty Syringe with Cannula 5.0ccNOVABONE PRODUCTS, LLCMQV2026-01-28
00813909014005Putty Syringe with Cannula 10.0ccNOVABONE PRODUCTS, LLCMQV2026-01-28
00813909013961Putty Syringe 2.5ccNOVABONE PRODUCTS, LLCMQV2026-01-09
00813909013978Putty Syringe 5.0ccNOVABONE PRODUCTS, LLCMQV2026-01-09
00850009685346Backpack AFVentris MedicalMQV2026-01-02
00850009685353Backpack AFVentris MedicalMQV2026-01-02
00813909013909Putty 2.5ccNOVABONE PRODUCTS, LLCMQV2025-12-26
00813909013916Putty 5.0ccNOVABONE PRODUCTS, LLCMQV2025-12-26
00813909013923Porous Morsels 1-2mm 5.0ccNOVABONE PRODUCTS, LLCMQV2025-12-26
00813909013930Porous Morsels 1-2mm 10.0ccNOVABONE PRODUCTS, LLCMQV2025-12-26
00813909013947Putty Syringe 2.5ccNOVABONE PRODUCTS, LLCMQV2025-12-26
00813909013954Putty Syringe 5.0ccNOVABONE PRODUCTS, LLCMQV2025-12-26
05060548020620InteliGraft™BIOSTONE CO. LIMITEDMQV2025-12-10