| Primary Device ID | 08800017101422 |
| NIH Device Record Key | d74aa88d-80d6-43dd-b503-5a36d1990902 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PlaDuo PRO System |
| Version Model Number | PlaDuo PRO System |
| Company DUNS | 690425442 |
| Company Name | shenb 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 | false |
| Lot Batch | false |
| Serial Number | true |
| 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 | 08800017101422 [Primary] |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-07 |
| Device Publish Date | 2025-04-29 |
| 08800017101422 - PlaDuo PRO System | 2025-05-07Brand Name: PlaDuo PRO System (PlaDuo System) Model: PlaDuo PRO System |
| 08800017101422 - PlaDuo PRO System | 2025-05-07 Brand Name: PlaDuo PRO System (PlaDuo System) Model: PlaDuo PRO System |
| 08800017101118 - PlaDuo System | 2023-11-09 |
| 08800017100883 - VYBE RF | 2022-09-27 Brand Name: VYBE RF (VIVACE) Model: VYBE RF |
| 08800017100579 - Sterile Micro Needle Cartridge | 2021-12-16 Blister Pack |
| 08800017100616 - Sterile Micro Needle Cartridge | 2021-12-16 Blister Pack |
| 08800017100647 - Sterile Micro Needle Cartridge | 2021-12-16 Blister Pack |
| 08800017100678 - Sterile Micro Needle Cartridge | 2021-12-16 Blister Pack |
| 08800017100753 - Sterile Micro Needle Cartridge | 2021-12-16 Blister Pack |