Product code NTX

Device name

Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)

Medical specialty

General Hospital

Device class

1

Regulation number

880.5630

Review panel

HO

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

A NURSING PAD CONSISTING OF A POLYURETHANE PAD WITH GLYCERIN USED TO RELIEVE NIPPLES THAT ARE SORE AND CRACKED FROM BREASTFEEDING.

Source

FDA openFDA device classification dataset