Product code PGZ

Device name

Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4452

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

To control bleeding in junctional, non-compressible wounds until surgical care is acquired.

Source

FDA openFDA device classification dataset