Product code OEE

Device name

Diagnostic Low Electric Field

Medical specialty

Unknown

Device class

3

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

As an adjunctive tool to guide the shavings of tissue at the margins of the tumor for use in excisional breast surgery to assist in locating the tissue for excision. In addition to other standard methods such as intraoperative imaging and palpation.

Source

FDA openFDA device classification dataset