| Primary Device ID | 00361554000923 |
| NIH Device Record Key | 0d4e632e-d250-4293-acfd-92606ed9cfe1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Calcium Alginate Dressing (6x6 in) |
| Version Model Number | GEN-13700 |
| Catalog Number | GEN-13700 |
| Company DUNS | 170967876 |
| Company Name | Gentell, LLC |
| Device Count | 10 |
| DM Exempt | true |
| 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 | 00361554000909 [Unit of Use] |
| GS1 | 00361554000916 [Primary] |
| GS1 | 00361554000923 [Package] Contains: 00361554000916 Package: Case [5 Units] In Commercial Distribution |
| 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 |
| 00361554007229 - Gentell | 2025-09-03 GEN13022 Gelling Fiber Ag Dressing 2”x2” (5cmx5cm) |
| 00361554007250 - Gentell | 2025-09-03 GEN13044 Gelling Fiber Ag Dressing 4”x4” (10cmx10cm) |
| 00361554007182 - Gentell | 2025-09-03 GEN13066 Gelling Fiber Ag Dressing 6”x6” (15cmx15cm) |
| 00361554003375 - Gentell | 2025-08-29 GEN13020 Gelling Fiber Dressing 2”x2” (5cmx5cm) |
| 00361554001098 - Gentell | 2025-08-29 GEN13040 Gelling Fiber Dressing 4”x4” (10cmx10cm) |
| 00361554001128 - Gentell | 2025-08-29 GEN13060 Gelling Fiber Dressing 6”x6” (15cmx15cm) |
| 15056860000072 - Gentell Hydrogel Sheet Dressing | 2025-08-29 GEN-11470 Gentell Hydrogel Sheet Dressing, 120mm x 86mm (4.7” x 3.4”), Borderless |
| 15056860000089 - Gentell Hydrogel Sheet Dressing | 2025-08-29 GEN-11700 Gentell Hydrogel Sheet Dressing, 178mm x 127mm (7” x 5”), Borderless |