Product code NAC
- Device name
- Dressing, Wound, Hydrophilic
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4018
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06974692681561 | GUANGYI | Jiangsu Guangyi Medical Dressing Co.,LTD. | 2026-07-22 |
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| 01714196635500 | HydraLock SA with Border | Sion Brands LLC | 2026-07-16 |
| 01714196637702 | HydraLock SA with Border | Sion Brands LLC | 2026-07-16 |
| 10197344175963 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-07-13 |
| 10197344175970 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-07-13 |
| 10197344175987 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-07-13 |
| 00850088144314 | CARBOU | Ningbo kehu Medical Technology Co.,Ltd. | 2026-07-08 |
| 00197344111513 | CURAD | MEDLINE INDUSTRIES, INC. | 2026-07-03 |
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| 00197998295850 | Solventum™ Kerracel™ | Solventum US LLC | 2026-06-27 |
| 00197998295812 | Solventum™ Kerracel™ | Solventum US LLC | 2026-06-27 |
| 00197998001727 | Solventum™ Kerracel™ | Solventum US LLC | 2026-06-27 |
| 00850087488440 | Ceeport | CEEPORT INC. | 2026-05-29 |
| 00850087488518 | Ceeport | CEEPORT INC. | 2026-05-29 |
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| 00324357410085 | Zeni Medical | Focus Health Group, Inc. | 2026-04-13 |
| 00324357410092 | Zeni Medical | Focus Health Group, Inc. | 2026-04-13 |
| 00324357410108 | Zeni Medical | Focus Health Group, Inc. | 2026-04-13 |
| 00324357410115 | Zeni Medical | Focus Health Group, Inc. | 2026-04-13 |
| 00324357410122 | Zeni Medical | Focus Health Group, Inc. | 2026-04-13 |
| 00324357410139 | Zeni Medical | Focus Health Group, Inc. | 2026-04-13 |
| 00324357410146 | Zeni Medical | Focus Health Group, Inc. | 2026-04-13 |
| 00361554003818 | Gentell | Gentell, LLC | 2024-11-29 |
| 00361554003870 | Gentell | Gentell, LLC | 2024-11-29 |
| 00819143021069 | Healqu | Healqu LLC | 2023-11-08 |
| 00819143021052 | Healqu | Healqu LLC | 2023-11-08 |
| 00850031608146 | Vitale STRONG | CELLERA LLC | 2023-02-15 |
| 04042809557305 | Cutimed® Siltec® | BSN medical GmbH | 2022-12-08 |