| Primary Device ID | M386565100501 |
| NIH Device Record Key | dd29e89b-66ea-48e1-9b3e-9acf96115f04 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OsteoSurge 300C Putty |
| Version Model Number | 56510050 |
| Catalog Number | 56510050 |
| Company DUNS | 801089152 |
| Company Name | ISOTIS ORTHOBIOLOGICS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | true |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)550-7155 |
| irvine.customerservice@seaspin | |
| Phone | +1(800)550-7155 |
| irvine.customerservice@seaspin |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889981055875 [Primary] |
| HIBCC | M386565100501 [Secondary] |
| MQV | FILLER, BONE VOID, CALCIUM COMPOUND |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-24 |
| M386565101001 | OsteoSurge300c Putty, 10cc - demineralized human bone and cancellous chips mixed with poloxamer |
| M386565100501 | OsteoSurge300c Putty, 5cc - demineralized human bone and cancellous chips mixed with poloxamer |
| M386565100251 | OsteoSurge300c Putty, 2.5cc - demineralized human bone and cancellous chips mixed with poloxame |