Product code OEI

Device name

Drainage Catheter With Antibiotic

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4780

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

A tubular drain made from silicone or similar material and is coated with a silver containing material and is intended to drain fluids from body cavities using gravity drainage or attached to a suction pump.

Source

FDA openFDA device classification dataset