NQR — Sealant, Dural Class III
FDA product code NQR covers "Sealant, Dural", a Class III medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.
Classification Details
- Product Code
- NQR
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Unknown
- Implant
- Yes
Definition
Dural sealants are devices intended to aid in preventing cerebrospinal fluid leakage through suture-approximated dural wound edges. The sealant is sprayed or layered onto sutured dural wound edges and allowed to polymerize in place.