FDA.reportPublic FDA data

Bio-Reign 3D

Primary DI
00850014593766
Brand
Bio-Reign 3D
Company
ROYAL BIOLOGICS INC.
Model
BR-s25x125x5
Catalog number
BR-s25x125x5
Device description
Bio-Reign 3D Sheet 25mm x 125mm x 5mm
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
00850014593766PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850014593766008500145937668500145937660850014593766

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
00850014593650Bio-Reign 3DBR-G5BR-G52023-02-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07610221017867Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017874Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017881Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017898Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017904Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017911Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017928Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
03760191133723GlassBone GranulesNORAKERMQV2026-05-27
03760191133730GlassBone GranulesNORAKERMQV2026-05-27
03760191133747GlassBone GranulesNORAKERMQV2026-05-27
03760191133754GlassBone GranulesNORAKERMQV2026-05-27
03760191133761GlassBone GranulesNORAKERMQV2026-05-27
03760191133778GlassBone GranulesNORAKERMQV2026-05-27
03760191133785GlassBone GranulesNORAKERMQV2026-05-27
03760191134812AktiBone GranulesNORAKERMQV2026-05-27
03760191134829AktiBone GranulesNORAKERMQV2026-05-27
03760191134836AktiBone GranulesNORAKERMQV2026-05-27
03760191134843AktiBone GranulesNORAKERMQV2026-05-27
03760191134850AktiBone GranulesNORAKERMQV2026-05-27
03760191134867AktiBone GranulesNORAKERMQV2026-05-27
03760191134874AktiBone GranulesNORAKERMQV2026-05-27
03760191134881MectaBlast GranulesNORAKERMQV2026-05-27
03760191134898MectaBlast GranulesNORAKERMQV2026-05-27
03760191134904MectaBlast GranulesNORAKERMQV2026-05-27
03760191134911MectaBlast GranulesNORAKERMQV2026-05-27