ReBOSSIS ORB-0310C
GUDID 04573190050323
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 Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft| Primary Device ID | 04573190050323 |
| NIH Device Record Key | 40ce9aab-7c39-44df-8b6e-6ee55620fceb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ReBOSSIS |
| Version Model Number | 1.0g |
| Catalog Number | ORB-0310C |
| 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 |
| dblake@orthorebirthusa.com |
Device Dimensions
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 Milliliter |
| Total Volume | 25 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 |
| 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 | 04573190050323 [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 | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-09-11 |
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 |
Trademark Results [ReBOSSIS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REBOSSIS 85602550 4564667 Live/Registered |
Orthorebirth Co., Ltd. 2012-04-19 |
 REBOSSIS 79232932 5694086 Live/Registered |
ORTHOREBIRTH CO., LTD. 2018-03-07 |
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