| Device Type ID | 2661 |
| Device Name | Disinfectant, Medical Devices |
| Regulation Description | General Purpose Disinfectants. |
| 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) Exempt |
| CFR Regulation Number | 880.6890 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | LRJ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2661 |
| Device | Disinfectant, Medical Devices |
| Product Code | LRJ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | General Purpose Disinfectants. |
| CFR Regulation Number | 880.6890 [🔎] |
| Device Problems | |
|---|---|
Device Disinfection Or Sterilization Issue | 4 |
Device Expiration Issue | 4 |
Device Rinsing Issue | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Chemical Problem | 2 |
Appropriate Term/Code Not Available | 2 |
Device Reprocessing Problem | 2 |
Chemical Spillage | 2 |
Device Contamination With Biological Material | 1 |
Failure To Disinfect | 1 |
Shelf Life Exceeded | 1 |
Product Quality Problem | 1 |
Maintenance Does Not Comply To Manufacturers Recommendations | 1 |
| Total Device Problems | 27 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Metrex Research, LLC. | II | Mar-03-2017 |