| Primary Device ID | 00850060751004 |
| NIH Device Record Key | 8fdcc4bf-e9a1-4d5e-996f-39e4ed1fd424 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SkinPen Precision Elite |
| Version Model Number | REF200 |
| Catalog Number | F5SP386 |
| 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 | 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 | 00850060751004 [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 | 2024-10-09 |
| Device Publish Date | 2024-10-01 |
| 00850060751035 | SPP Elite Microneedling System |
| 00850060751073 | SPP Elite Microneedling Cartridge |
| 00850060751011 | SPP Elite Charging Base |
| 00850060751004 | SPP Elite Microneedling Handpiece |