Product code NQR

Device name

Sealant, Dural

Medical specialty

Unknown

Device class

3

Review panel

NE

Implant

Y

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset