FDA.reportPublic FDA data

Bio-Reign 3D

Primary DI
00850014593650
Brand
Bio-Reign 3D
Company
ROYAL BIOLOGICS INC.
Model
BR-G5
Catalog number
BR-G5
Device description
Bio-Reign 3D Granules 5cc
Published
2023-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
00850014593650PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850014593650008500145936508500145936500850014593650

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 201-488-1549support@royalbiologics.com

Regulatory Flags#

DUNS number
080562141
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014593629BioIncyte5103565103562023-02-10
00850014593636SeriVium5103555103552023-02-10
00850014593643AlVeo5103545103542023-02-10
00850014593018FIBRINETPRFMK5103572023-02-10
00850014593025FIBRINETPRFMK5103582023-02-10
00850014593032FIBRINETPFRMK5103592023-02-10
10850014593626BioIncyte5103565103562023-02-10
10850014593633SeriVium5103555103552023-02-10
10850014593640AlVeo5103545103542023-02-10
00850014593667Bio-Reign 3DBR-G10BR-G102023-02-10
00850014593674Bio-Reign 3DBR-G20BR-G202023-02-10
00850014593681Bio-Reign 3DBR-G30BR-G302023-02-10
00850014593698Bio-Reign 3DBR-s25x25x3BR-s25x25x32023-02-10
00850014593704Bio-Reign 3DBR-s25x50x3BR-s25x50x32023-02-10
00850014593711Bio-Reign 3DBR-s25x75x3BR-s25x75x32023-02-10
00850014593728Bio-Reign 3DBR-s25x125x3BR-s25x125x32023-02-10
00850014593735Bio-Reign 3DBR-s25x25x5BR-s25x25x52023-02-10
00850014593742Bio-Reign 3DBR-s25x50x5BR-s25x50x52023-02-10
00850014593759Bio-Reign 3DBR-s25x75x5BR-s25x75x52023-02-10
00850014593766Bio-Reign 3DBR-s25x125x5BR-s25x125x52023-02-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00816125027149VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
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ECUR9920310VerteFramecurasan AGMQV2026-06-25
ECURCCLF25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLF25250CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLF2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2512CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2525CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURTFF1050TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFF1100TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFM1050TriForm Moldable Foamcurasan AGMQV2026-06-25
ECURTFM1100TriForm Moldable Foamcurasan AGMQV2026-06-25
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06429810349293Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349316Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349330Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349354Adaptos®FuseBiomendex OyMQV2026-06-24
W4184058150T0474DBX®Musculoskeletal Transplant Foundation, Inc.MQV2026-06-05
07610221017829Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017836Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017843Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017850Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01