| Primary Device ID | 08809255544633 |
| NIH Device Record Key | 91e119ef-2f23-4c20-b3d4-7f7af07a8d6f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GUARDIAN-SG Inflatable Bone Expander System |
| Version Model Number | BMK(T)15αS |
| Company DUNS | 557799209 |
| Company Name | BM KOREA CO., LTD |
| 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 | true |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *temperature limitation, from -10℃ to 25℃ |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809255542639 [Primary] |
| GS1 | 08809255544633 [Package] Contains: 08809255542639 Package: [10 Units] In Commercial Distribution |
| NDN | Cement, Bone, Vertebroplasty |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-05-06 |
| Device Publish Date | 2017-06-21 |
| 08809255544633 | The GUARDIAN-SG Inflatable Bone Expander System is intended to be used for the reduction of frac |
| 08809255540987 | The GUARDIAN-SG Inflatable Bone Expander System is intended to be used for the reduction of frac |