| Primary Device ID | 00818257022122 |
| NIH Device Record Key | 28aa43f9-2c7a-4235-b27b-828279a5a943 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Derma Genesis Infusion |
| Version Model Number | D11-0358-101 |
| Catalog Number | D11-0358-101 |
| Company DUNS | 067933700 |
| Company Name | GENESIS BIOSYSTEMS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 9723157888 |
| customerservice@genesisbiosystems.com | |
| Phone | 9723157888 |
| customerservice@genesisbiosystems.com | |
| Phone | 9723157888 |
| customerservice@genesisbiosystems.com | |
| Phone | 9723157888 |
| customerservice@genesisbiosystems.com | |
| Phone | 9723157888 |
| customerservice@genesisbiosystems.com | |
| Phone | 9723157888 |
| customerservice@genesisbiosystems.com | |
| Phone | 9723157888 |
| customerservice@genesisbiosystems.com | |
| Phone | 9723157888 |
| customerservice@genesisbiosystems.com | |
| Phone | 9723157888 |
| customerservice@genesisbiosystems.com | |
| Phone | 9723157888 |
| customerservice@genesisbiosystems.com | |
| Phone | 9723157888 |
| customerservice@genesisbiosystems.com | |
| Phone | 9723157888 |
| customerservice@genesisbiosystems.com | |
| Phone | 9723157888 |
| customerservice@genesisbiosystems.com | |
| Phone | 9723157888 |
| customerservice@genesisbiosystems.com | |
| Phone | 9723157888 |
| customerservice@genesisbiosystems.com | |
| Phone | 9723157888 |
| customerservice@genesisbiosystems.com | |
| Phone | 9723157888 |
| customerservice@genesisbiosystems.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00818257022122 [Primary] |
| GFE | Brush, Dermabrasion, Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-01 |
| Device Publish Date | 2023-07-24 |
| 00818257022122 - Derma Genesis Infusion | 2023-08-01Multi Modality Micro-Exfolaition system |
| 00818257022122 - Derma Genesis Infusion | 2023-08-01 Multi Modality Micro-Exfolaition system |
| 00818257020074 - CoolBreeze | 2020-02-24 Cool Breeze LED Wand - Red |
| 00818257020081 - CoolBreeze | 2020-02-24 Cool Breeze LED wand - Blue |
| 00818257020012 - LipiVage® | 2018-03-29 LipiVage Harvester |
| 00818257020029 - LipiVage® | 2018-03-29 LipiVage Harvester with cannula |