Definition: Provides Automated Loading And Unloading Of Instruments Requiring Sterilization For Increasing Hospital Work Flow Efficiencies. The System Consists Of A User Interface, Loading Conveyor, Load Transport Shuttles, Unloading Conveyor To Be Used As An Ac
| Device Type ID | 2738 |
| Device Name | Sterilizer Automated Loading System |
| Physical State | The System Consists Of A Single Point User Interface Station, Loading Conveyor, Load Transport Shuttles, Unloading Conveyor And A Sterilizer That Sits On A Loading Car. |
| Technical Method | Works In Conjunction With A Steam Sterilizer |
| Target Area | NA |
| Regulation Description | Steam 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 | 880.6880 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PEC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2738 |
| Device | Sterilizer Automated Loading System |
| Product Code | PEC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Steam Sterilizer. |
| CFR Regulation Number | 880.6880 [🔎] |
| Device Problems | |
|---|---|
Break | 1 |
| Total Device Problems | 1 |