OLS — Oral Wound Dressing W/Drug And/Or Biologic Class U
FDA product code OLS covers "Oral Wound Dressing W/Drug And/Or Biologic", a Class U medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- OLS
- Device Class
- Class U
- Regulation Number
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Unknown
- Implant
- No
Definition
Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per se to mgq.