| Primary Device ID | 00361554000879 |
| NIH Device Record Key | e9c52818-0ffa-4fad-88a9-937dbb778074 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Calcium Alginate Dressing (4x8 in) |
| Version Model Number | GEN-13480 |
| Catalog Number | GEN-13480 |
| Company DUNS | 170967876 |
| Company Name | Gentell, LLC |
| Device Count | 10 |
| 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 | true |
| Lot Batch | true |
| Serial Number | true |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00361554000879 [Unit of Use] |
| GS1 | 00361554000886 [Primary] |
| NAC | Dressing, Wound, Hydrophilic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-24 |
| Device Publish Date | 2025-02-14 |
| 00361554000862 - Calcium Alginate Dressing (4x4 in) | 2025-02-24 |
| 00361554000879 - Calcium Alginate Dressing (4x8 in) | 2025-02-24 |
| 00361554000879 - Calcium Alginate Dressing (4x8 in) | 2025-02-24 |
| 00361554000923 - Calcium Alginate Dressing (6x6 in) | 2025-02-24 |
| 00361554000954 - Calcium Alginate Dressing (10x10 in) | 2025-02-24 |
| 00361554002927 - Calcium Alginate Dressing (2x2 in) | 2025-02-24 |
| 00361554005584 - Gentell | 2025-02-24 Hydrogel Sheet Dressing 2.4"x 2.4" |
| 00361554005607 - Gentell | 2025-02-24 Hydrogel Sheet Dressing 7"x5" |
| 00361554005621 - Gentell | 2025-02-24 Hydrogel Sheet Dressing 4.7"x3.4" |