| Primary Device ID | 00850035498873 |
| NIH Device Record Key | c2e1776b-49c2-49fb-b657-3907f2fb8bd2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SkinPen Precision Premium Treatment Kit |
| Version Model Number | F5SP391 |
| Catalog Number | F5SP391 |
| Company DUNS | 005677967 |
| Company Name | Bellus Medical, LLC |
| 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 | false |
| 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 | 00850035498873 [Primary] |
| QAI | Powered Microneedle Device |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-08 |
| Device Publish Date | 2023-07-31 |
| 00850060751004 - SkinPen Precision Elite | 2024-10-09 SPP Elite Microneedling Handpiece |
| 00850060751011 - SkinPen Precision Elite | 2024-10-09 SPP Elite Charging Base |
| 00850060751073 - SkinPen Precision Elite | 2024-10-09 SPP Elite Microneedling Cartridge |
| 00850060751035 - SkinPen Precision Elite | 2024-10-09 SPP Elite Microneedling System |
| 00850060751127 - ProGen PRP Eclipse | 2024-09-05 15 mL Platelet Rich Plasma production device |
| 00850060751134 - ProGen PRP Eclipse | 2024-09-05 15mL Platelet Rich Plasma production device |
| 00850060751165 - ProGen PRP Eclipse | 2024-09-05 30mL Platelet Rich Plasma production device |
| 00850060751172 - ProGen PRP Eclipse | 2024-09-05 30mL Platelet Rich Plasma production device |