| Primary Device ID | 03760177042056 |
| NIH Device Record Key | 720e6d06-b352-484b-b78c-002cb8b5918f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OsSatura TCP |
| Version Model Number | Granules 3x3x3 10cc |
| Catalog Number | 05-6010-100 |
| Company DUNS | 764746723 |
| Company Name | TEKNIMED |
| 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 | true |
| Manufacturing Date | true |
| 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 Size Text, specify | 0 |
| Pore Size | 220 Micrometer |
| Weight | 6.3 Gram |
| Device Size Text, specify | 0 |
| Pore Size | 220 Micrometer |
| Weight | 6.3 Gram |
| Device Size Text, specify | 0 |
| Pore Size | 220 Micrometer |
| Weight | 6.3 Gram |
| Device Size Text, specify | 0 |
| Pore Size | 220 Micrometer |
| Weight | 6.3 Gram |
| Device Size Text, specify | 0 |
| Pore Size | 220 Micrometer |
| Weight | 6.3 Gram |
| Device Size Text, specify | 0 |
| Pore Size | 220 Micrometer |
| Weight | 6.3 Gram |
| Device Size Text, specify | 0 |
| Pore Size | 220 Micrometer |
| Weight | 6.3 Gram |
| Device Size Text, specify | 0 |
| Pore Size | 220 Micrometer |
| Weight | 6.3 Gram |
| Device Size Text, specify | 0 |
| Pore Size | 220 Micrometer |
| Weight | 6.3 Gram |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03760177042056 [Primary] |
| 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 | 5 |
| Public Version Date | 2020-10-26 |
| Device Publish Date | 2015-10-16 |
| 03760177042070 | Granules 3x3x3 30cc |
| 03760177042056 | Granules 3x3x3 10cc |
| 03760177042049 | Granules 3x3x3 5cc |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OSSATURA TCP 78389398 3177789 Dead/Cancelled |
IsoTis OrthoBiologics, Inc. 2004-03-23 |