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
Primary Device ID04573190050538
NIH Device Record Keyfd02beb8-219f-4097-b68d-35053c87ea0f
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioCera Fibers
Version Model Number0.4g
Catalog NumberORB-0304C-KC
Company DUNS691435666
Company NameORTHOREBIRTH CO.,LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104573190050538 [Primary]

FDA Product Code

MQVFiller, Bone Void, Calcium Compound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-02
Device Publish Date2024-03-25

On-Brand Devices [BioCera Fibers]

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

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