| Primary Device ID | 00850035498286 |
| NIH Device Record Key | a78dd0bd-1b9d-4535-b100-64cf7452513a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SP MicroPen EVO |
| Version Model Number | F5SP216 |
| 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 | 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 | 00850035498262 [Primary] |
| GS1 | 00850035498286 [Package] Contains: 00850035498262 Package: System Assembly [1 Units] In Commercial Distribution |
| GS1 | 00850035498347 [Package] Contains: 00850035498262 Package: [1 Units] In Commercial Distribution |
| 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 | 2022-06-02 |
| Device Publish Date | 2022-05-25 |
| 00850035498873 - SkinPen Precision Premium Treatment Kit | 2023-08-08 Treatment kit which includes a sterile, disposable cartridge tip, a hydrogel, and a disposable sleeve. |
| 00850035498286 - SP MicroPen EVO | 2022-06-02MicroPen EVO Microneedling Device |
| 00850035498286 - SP MicroPen EVO | 2022-06-02 MicroPen EVO Microneedling Device |
| 10850035498290 - SP MicroPen EVO Microneedling Cartridge | 2022-06-02 MicroPen EVO Turbo Safety Cartridge (each). Cartridges are sterilized and packaged individually for single patient use. |
| 00850035498392 - Progen PRP Advantage | 2022-05-17 15 mL Blood Draw Kit - Single |
| 00850035498408 - Progen PRP Advantage | 2022-05-17 30 ml Blood Draw Kits |
| 00850035498415 - Progen PRP Advantage | 2022-05-02 Progen PRP Advantage Kits - 15 ml PRP Tubes and Blood Draw Kit |
| 00850035498422 - Progen PRP Advantage | 2022-05-02 Progen PRP Advantage Kits - 30 ml PRP Tubes and Blood Draw Kit |
| 00850035498439 - Progen PRP Advantage | 2022-05-02 Progen PRP Advantage Kits - 15 ml PRP tubes and Blood Draw Kit |