BioCera Fibers ORB-0320C-KC

GUDID 04573190050514

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

• Primary Device ID: 04573190050514
• NIH Device Record Key: 93111a9b-fd9c-46b0-aa9d-f7ab961979f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioCera Fibers
• Version Model Number: 2.0g
• Catalog Number: ORB-0320C-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: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 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	04573190050514 [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