ReBOSSIS ORB-0302C
GUDID 04573190050309
ReBOSSIS 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 results in a cotton-like physical form. Due to its physical form, ReBOSSIS is flexible and can easily fill defects in appropriate amounts.
ORTHOREBIRTH CO.,LTD.
Synthetic bone graft| Primary Device ID | 04573190050309 |
| NIH Device Record Key | 15a229cb-b572-4df8-a09b-baf84f5f9bac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ReBOSSIS |
| Version Model Number | 0.2g |
| Catalog Number | ORB-0302C |
| 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 |
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 |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04573190050309 [Primary] |
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 | 2024-09-09 |
| Device Publish Date | 2024-09-01 |
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 |
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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