| Primary Device ID | M386562300501 |
| NIH Device Record Key | 82044efa-e844-44c6-9806-1f8d275f067e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OsteoSparx C Putty |
| Version Model Number | 56230050 |
| Catalog Number | 56230050 |
| 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 | 10889981055776 [Primary] |
| HIBCC | M386562300501 [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 |
| M386562301001 | OsteoSparx C Putty, 10cc - derived from selected donated human bone tissue that has been process |
| M386562300501 | OsteoSparx C Putty, 5cc - derived from selected donated human bone tissue that has been processe |