ReBOSSIS ORB-0120B

GUDID 04573190050118

ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalcium phosphate, siloxane-containin

ORTHOREBIRTH CO.,LTD.

Synthetic bone graft

• Primary Device ID: 04573190050118
• NIH Device Record Key: 8b7c9ccf-417a-459d-a7fb-8054b7170972
• Commercial Distribution Discontinuation: 2018-11-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ReBOSSIS
• Version Model Number: 2.0g
• Catalog Number: ORB-0120B
• 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: 50 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04573190050118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142090

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-12
• Device Publish Date: 2015-09-24

On-Brand Devices [ReBOSSIS]

• 04573190050347: ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material consi
• 04573190050330: ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material consi
• 04573190050323: ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material consi
• 04573190050316: ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material consi
• 04573190050231: ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material consi
• 04573190050224: ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material consi
• 04573190050132: ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material consi
• 04573190050125: ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material consi
• 04573190050118: ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material consi
• 04573190050033: ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material consi
• 04573190050026: ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material consi
• 04573190050019: ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material consi
• 04573190050392: ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material consi
• 04573190050385: ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material consi
• 04573190050378: ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material consi
• 04573190050309: ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material consi