Product code PBY
- Device name
- Temporary Tissue Marker
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4300
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- To temporarily (< 30 days) mark a tissue site intended for surgical removal. The tissue marker is surgically removed with the target tissue.
- Source
- FDA openFDA device classification dataset