| Device Type ID | 2592 |
| Device Name | Bandage, Elastic |
| Regulation Description | Elastic Bandage. |
| 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) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.5075 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FQM |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2592 |
| Device | Bandage, Elastic |
| Product Code | FQM |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Elastic Bandage. |
| CFR Regulation Number | 880.5075 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 12 |
Appropriate Term/Code Not Available | 11 |
Device Operates Differently Than Expected | 2 |
Device Packaging Compromised | 2 |
Off-Label Use | 1 |
Leak / Splash | 1 |
Sticking | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Use Of Device Problem | 1 |
Material Frayed | 1 |
| Total Device Problems | 33 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Amd-Ritmed, Inc. | II | Jul-15-2016 |
| 2 | Johnson & Johnson Consumer, Inc. | II | Mar-27-2018 |
| 3 | Medline Industries Inc | II | Dec-29-2017 |
| 4 | Medline Industries Inc | II | Jan-23-2017 |
| 5 | Medline Industries Inc | II | May-21-2014 |
| 6 | Tactical Medical Solutions, Inc. | II | Jul-25-2018 |