Product code JZR
- Device name
- Support Gels
- Medical specialty
- Immunology
- Device class
- 1
- Regulation number
- 866.4900
- Review panel
- IM
- 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 |
|---|---|---|---|
| 00643293008911 | Oasis | TRULIFE LIMITED | 2023-01-09 |
| 00643293009130 | Oasis | TRULIFE LIMITED | 2023-01-09 |
| 00643293009116 | Oasis | TRULIFE LIMITED | 2023-01-09 |
| 00643293009093 | Oasis | TRULIFE LIMITED | 2023-01-09 |
| 00643293009086 | Oasis | TRULIFE LIMITED | 2023-01-09 |
| 00643293009079 | Oasis | TRULIFE LIMITED | 2023-01-09 |
| 00643293009024 | Oasis | TRULIFE LIMITED | 2023-01-09 |
| 00643293009017 | Oasis | TRULIFE LIMITED | 2023-01-09 |
| 00643293009000 | Oasis | TRULIFE LIMITED | 2023-01-09 |
| 00643293008997 | Oasis | TRULIFE LIMITED | 2023-01-09 |
| 00643293008980 | Oasis | TRULIFE LIMITED | 2023-01-09 |
| 00643293008973 | Oasis | TRULIFE LIMITED | 2023-01-09 |
| 00643293008966 | Oasis | TRULIFE LIMITED | 2023-01-09 |
| 00643293008959 | Oasis | TRULIFE LIMITED | 2023-01-09 |
| 00643293008942 | Oasis | TRULIFE LIMITED | 2023-01-09 |
| 00643293008904 | Oasis | TRULIFE LIMITED | 2023-01-09 |
| 00643293008874 | Oasis | TRULIFE LIMITED | 2023-01-09 |
| 00643293008843 | Oasis | TRULIFE LIMITED | 2023-01-09 |
| 00643293008836 | Oasis | TRULIFE LIMITED | 2023-01-09 |
| 00643293008829 | Oasis | TRULIFE LIMITED | 2023-01-09 |
| 00643293008812 | Oasis | TRULIFE LIMITED | 2023-01-09 |
| 00643293008805 | Oasis | TRULIFE LIMITED | 2023-01-09 |
| 00643293008799 | Oasis | TRULIFE LIMITED | 2023-01-09 |
| 00643293008782 | Oasis | TRULIFE LIMITED | 2023-01-09 |
| 00643293008775 | Oasis | TRULIFE LIMITED | 2023-01-09 |
| 00643293008768 | Oasis | TRULIFE LIMITED | 2023-01-09 |
| M52530470 | TITAN GEL IEP Kit (10 gels) | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M52590150 | IEP Sponge Wicks (2/pkg) | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M52590090 | Double Diffusion Plates (10/pkg) | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M52530490 | TITAN GEL IEP Stain (1 x 10 g powder) | HELENA LABORATORIES CORPORATION | 2017-03-17 |