DeviceClearance

Product code NTX— General Hospital

FERRIS POLYMEM STERILE BREAST PAD

Classification name
Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)
Device class
Class 1
Regulation
21 CFR 880.5630
Advisory panel
General Hospital
Total cleared
1
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code NTX under 21 CFR 880.5630, via openFDA

Market context for product code NTX

FDA has cleared 1 device under product code NTX, all in 2005, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code NTX

Recent clearances under product code NTX

Data sourced from openFDA. This site is unofficial and independent of the FDA.