Definition: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.Fda.Gov/cdrh/ode/convkit.Html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is
| Device Type ID | 5472 |
| Device Name | Wound Dressing Kit |
| Physical State | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.Fda.Gov/cdrh/ode/convkit.Html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is |
| Technical Method | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.Fda.Gov/cdrh/ode/convkit.Html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is |
| Target Area | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.Fda.Gov/cdrh/ode/convkit.Html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is |
| Regulation Description | Elastic Bandage. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1) |
| Submission Type | Enforcement Discretion |
| CFR Regulation Number | 880.5075 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MCY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5472 |
| Device | Wound Dressing Kit |
| Product Code | MCY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Elastic Bandage. |
| CFR Regulation Number | 880.5075 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Customed, Inc | II | Apr-14-2016 |
| 2 | Customed, Inc | II | Sep-03-2015 |
| 3 | Customed, Inc | I | Dec-16-2014 |