| Primary Device ID | 07898616351431 |
| NIH Device Record Key | d61d517c-a448-4c78-a133-8b38918a23ad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OstomyGel |
| Version Model Number | 290010003 |
| Catalog Number | 290010003 |
| Company DUNS | 904563269 |
| Company Name | DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDA |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07898616351431 [Primary] |
| GDS | Bag, Stomal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-06 |
| Device Publish Date | 2025-04-28 |
| 07898616351431 - OstomyGel | 2025-05-06Ostomy accessory |
| 07898616351431 - OstomyGel | 2025-05-06 Ostomy accessory |
| 07898616351400 - e-light I-US | 2025-03-13 Laser system for therapy |
| 07898616351417 - e-light B-US | 2025-03-13 Heat source for bleaching teeth |
| 07898616351424 - e-light V-US | 2025-03-13 Heat source for bleaching teeth |
| 07898616351127 - Therapy EC (FDA) | 2025-01-29 Laser system for therapy |
| 07898616351134 - Therapy XT (FDA) | 2025-01-29 Laser system for therapy |