BioCera Fibers QDS ORB-0305D-KC

GUDID 04573190050552

BioCera Fibers QDS 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 QDS results in a cotton-like physical form. Due to its physical form, BioCera Fibers QDS is flexible and can easily fill defects in appropriate amounts.

ORTHOREBIRTH CO.,LTD.

Synthetic bone graft
Primary Device ID04573190050552
NIH Device Record Key2210647b-947a-43f4-8dfb-d153c7feec8e
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioCera Fibers QDS
Version Model Number0.25g
Catalog NumberORB-0305D-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 Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 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

Device Identifiers

Device Issuing AgencyDevice ID
GS104573190050552 [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 Date2025-06-05
Device Publish Date2025-05-28

Devices Manufactured by ORTHOREBIRTH CO.,LTD.

04573190050613 - ZENBONE2025-06-24 ZENBONE is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalcium phosphat
04573190050620 - ZENBONE2025-06-24 ZENBONE is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalcium phosphat
04573190050637 - ZENBONE2025-06-24 ZENBONE is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalcium phosphat
04573190050552 - BioCera Fibers QDS2025-06-05BioCera Fibers QDS 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 QDS results in a cotton-like physical form. Due to its physical form, BioCera Fibers QDS is flexible and can easily fill defects in appropriate amounts.
04573190050552 - BioCera Fibers QDS2025-06-05 BioCera Fibers QDS is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalci
04573190050309 - ReBOSSIS2024-09-09 ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalcium phospha
04573190050378 - ReBOSSIS2024-09-09 ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalcium phospha
04573190050385 - ReBOSSIS2024-09-09 ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalcium phospha
04573190050392 - ReBOSSIS2024-09-09 ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalcium phospha
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