ReBOSSIS QDS ORB-0305D

GUDID 04573190050361

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

ORTHOREBIRTH CO.,LTD.

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• Primary Device ID: 04573190050361
• NIH Device Record Key: 766b3dce-6fef-48ef-921e-91277138325f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReBOSSIS QDS
• Version Model Number: 0.25g
• Catalog Number: ORB-0305D
• 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

Customer Support Contacts

• Phone: 866-426-2323
• Email: dblake@orthorebirthusa.com

Device Dimensions

• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter

Operating and Storage Conditions

• 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
• 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	04573190050361 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170620

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: 2019-11-11
• Device Publish Date: 2019-11-01

On-Brand Devices [ReBOSSIS QDS]

• 04573190050354: ReBOSSIS QDS is a cotton-like synthetic, resorbable bone void filler. It is composite material c
• 04573190050361: ReBOSSIS QDS is a cotton-like synthetic, resorbable bone void filler. It is composite material c