| Primary Device ID | 08055598060051 |
| NIH Device Record Key | 49728fbf-2784-41b8-8a80-0943ea1a2c8c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 1NEED Pro |
| Version Model Number | ASCAMPOMATS_1NEED_MN_PRO |
| Company DUNS | 442208550 |
| Company Name | CAMPOMATS SRL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | 08055598060051 [Package] Contains: 08055598060068 Package: carder box [5 Units] In Commercial Distribution |
| GS1 | 08055598060068 [Primary] |
| QAI | Powered Microneedle Device |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-11 |
| Device Publish Date | 2025-12-03 |
| 08055598060051 - 1NEED Pro | 2025-12-11Microneedling device. 1NEED Pro consists of Handpiece Holder - Power Supply with detachable cable - Instructions for Use |
| 08055598060051 - 1NEED Pro | 2025-12-11 Microneedling device. 1NEED Pro consists of Handpiece Holder - Power Supply with detachable cable - Instructions for Use |
| 08055598060082 - 1NEED Pro Cartridges | 2025-12-11 Box of 10 NOFLOW® Cartridges + 10 Protective sleeves to be used in combination with 1NEED Pro device. |