Definition: Intended For Use In Terminal Sterilization Of Cleaned, Rinsed, And Dried Metal And Non-metal Reusable Medical Devices In Health Care Facilities.
| Device Type ID | 2743 |
| Device Name | Two Or More Sterilant Sterilizer |
| Physical State | Sterilizer |
| Technical Method | The Sterilizer Is A Dual Sterilant Sterilizer Using Hydrogen Peroxide And Ozone As The Sterilant |
| Target Area | NA |
| Regulation Description | Ethylene Oxide Gas Sterilizer. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Infection Control Devices Branch (INCB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.6860 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PJJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2743 |
| Device | Two Or More Sterilant Sterilizer |
| Product Code | PJJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ethylene Oxide Gas Sterilizer. |
| CFR Regulation Number | 880.6860 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
TS03 INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TSO3 INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Improper Or Incorrect Procedure Or Method | 3 |
| Total Device Problems | 3 |