| Primary Device ID | M386560101001 |
| NIH Device Record Key | 05b449d1-cd86-4b9e-b032-668cc5c26776 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OsteoStrux Strip |
| Version Model Number | 56010100 |
| Catalog Number | 56010100 |
| 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 | 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 | 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 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889981056018 [Primary] |
| HIBCC | M386560101001 [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 | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-09-24 |
| M386560101501 | OsteoStrux® Strip 15cc - A resorbable bone void filler made from a bovine collagen matrix tha |
| M386560101001 | OsteoStrux® Strip 10cc - A resorbable bone void filler made from a bovine collagen matrix tha |
| M386560100501 | OsteoStrux® Strip 5cc - A resorbable bone void filler made from a bovine collagen matrix that |