BioCera Fibers ORB-0304C-KC

GUDID 04573190050538

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.

ORTHOREBIRTH CO.,LTD.

Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft

• Primary Device ID: 04573190050538
• NIH Device Record Key: fd02beb8-219f-4097-b68d-35053c87ea0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioCera Fibers
• Version Model Number: 0.4g
• Catalog Number: ORB-0304C-KC
• Company DUNS: 691435666
• Company Name: ORTHOREBIRTH CO.,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04573190050538 [Primary]

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-02
• Device Publish Date: 2024-03-25

On-Brand Devices [BioCera Fibers]

• 04573190050545: BioCera Fibers is a cotton-like synthetic, resorbable bone void filler. It is composite material
• 04573190050538: BioCera Fibers is a cotton-like synthetic, resorbable bone void filler. It is composite material
• 04573190050521: BioCera Fibers is a cotton-like synthetic, resorbable bone void filler. It is composite material
• 04573190050514: BioCera Fibers is a cotton-like synthetic, resorbable bone void filler. It is composite material