| Primary Device ID | 08809324764344 |
| NIH Device Record Key | 3f683545-132f-4853-b7b9-3609a9fd26ee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OSTEON II |
| Version Model Number | DT7G1020100 |
| Catalog Number | DT7G1020100 |
| Company DUNS | 690083006 |
| Company Name | GENOSS CO., Ltd. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 |
| Total Volume | 1 Milliliter |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809324764344 [Primary] |
| LYC | Bone grafting material, synthetic |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[08809324764344]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2016-03-09 |
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