| Primary Device ID | 08809317170077 |
| NIH Device Record Key | 37f0351b-802c-4779-9fd8-bbae025d3924 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | B-Two Inflatable bone expander system syringe |
| Version Model Number | US103002 |
| Company DUNS | 690340653 |
| Company Name | IMEDICOM 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809317170077 [Primary] |
| HRX | Arthroscope |
| 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 | 2016-09-27 |
| 08800038059894 - MEDINAUT MAX | 2024-11-25 Battery Shield |
| 08800038059863 - MEDINAUT MAX | 2024-11-22 4cell Battery |
| 08800038059870 - MEDINAUT MAX | 2024-11-22 4cell Battery Case |
| 08800038059887 - MEDINAUT MAX | 2024-11-22 2ch Charger |
| 08800038056114 - IMEDICOM SAW BLADE | 2024-11-20 |
| 08800038056121 - IMEDICOM SAW BLADE | 2024-11-20 |
| 08404535005516 - Brasseler EZX | 2024-09-16 Side handle for Brasseler EZX offset shaft |
| 00887919993124 - Brasseler EZX | 2024-05-07 |