| Device Type ID | 5582 |
| Device Name | Marker, Skin |
| Regulation Description | Skin Marker. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4660 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FZZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5582 |
| Device | Marker, Skin |
| Product Code | FZZ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Skin Marker. |
| CFR Regulation Number | 878.4660 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 13 |
Leak / Splash | 7 |
Improper Or Incorrect Procedure Or Method | 3 |
Patient-Device Incompatibility | 1 |
Chemical Spillage | 1 |
Detachment Of Device Component | 1 |
Patient Device Interaction Problem | 1 |
Biocompatibility | 1 |
| Total Device Problems | 28 |