FDA.reportPublic FDA data

BioCera Fibers

Primary DI
04573190050545
Brand
BioCera Fibers
Company
ORTHOREBIRTH CO.,LTD.
Model
0.2g
Catalog number
ORB-0302C-KC
Device description
BioCera Fibers is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalcium phosphate, siloxane-containing vaterite (a form of calcium carbonate), and poly(L-lactide co glycolide). The electrospinning process used in manufacturing BioCera Fibers results in a cotton-like physical form. Due to its physical form, BioCera Fibers is flexible and can easily fill defects in appropriate amounts.
Published
2024-03-25
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

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
04573190050545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04573190050545045731900505454573190050545

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume2Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
691435666
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04573190050613ZENBONE2.0gORB-0320C-Z2025-06-16
04573190050620ZENBONE1.0gORB-0310C-Z2025-06-16
04573190050637ZENBONE0.4gORB-0304C-Z2025-06-16
04573190050552BioCera Fibers QDS0.25gORB-0305D-KC2025-05-28
04573190050309ReBOSSIS0.2gORB-0302C2024-09-01
04573190050378ReBOSSIS2.0gORB-0320C2024-09-01
04573190050385ReBOSSIS1.0gORB-0310C2024-09-01
04573190050392ReBOSSIS0.4gORB-0304C2024-09-01
04573190050514BioCera Fibers2.0gORB-0320C-KC2024-03-25
04573190050521BioCera Fibers1.0gORB-0310C-KC2024-03-25
04573190050538BioCera Fibers0.4gORB-0304C-KC2024-03-25
04573190050361ReBOSSIS QDS0.25gORB-0305D2019-11-01
04573190050316ReBOSSIS2.0gORB-0320C2017-09-11
04573190050323ReBOSSIS1.0gORB-0310C2017-09-11
04573190050330ReBOSSIS0.7gORB-0307C2017-09-11
04573190050347ReBOSSIS0.4gORB-0304C2017-09-11
04573190050354ReBOSSIS QDS0.5gORB-0305D2018-05-30
04573190050019ReBOSSIS2.0gORB-0120S2015-09-24
04573190050026ReBOSSIS1.0gORB-0110S2015-09-24
04573190050033ReBOSSIS0.7gORB-0107S2015-09-24

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