Product code NNX

Device name

Device, Incontinence, Urosheath Type, Non-Sterile

Medical specialty

Gastroenterology, Urology

Device class

1

Regulation number

876.5250

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

Y

Third party review

N

Summary malfunction reporting

Eligible

Definition

Urine collector and accessories; see product code EXJ

Source

FDA openFDA device classification dataset