| Primary Device ID | 08809281659417 |
| NIH Device Record Key | 8b63647f-47f3-4345-be8a-0dd3ae60b128 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PCD System |
| Version Model Number | TYP-PCDA |
| Catalog Number | TYP-PCDA |
| Company DUNS | 687607387 |
| Company Name | Taeyeon Medical co.,Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 08809281659417 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-01 |
| Device Publish Date | 2025-08-22 |
| 08809281659301 - BALEX Bone Expander System | 2025-09-01 Kyphoplasty balloon catheter Definition: A sterile, flexible tube designed to be used for the creation of a void within a verteb |
| 08809281659325 - BALEX Bone Expander System | 2025-09-01 Kyphoplasty balloon catheter Definition: A sterile, flexible tube designed to be used for the creation of a void within a verteb |
| 08809281659370 - BALEX Bone Expander System | 2025-09-01 BALEX Bone Expander Systems are the device intended to insert the bone cement into the cavity made by the balloon tip in the fra |
| 08809281659417 - PCD System | 2025-09-01CEMENT DISPENSER SYSTEM (PCD) SET A |
| 08809281659417 - PCD System | 2025-09-01 CEMENT DISPENSER SYSTEM (PCD) SET A |