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

Device Code: 2700

Product Code(s): NTX

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

Device Classification Information

Device Type ID2700
Device NameNursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (f-68)
Regulation DescriptionNipple Shield.
Regulation Medical SpecialtyGeneral Hospital
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type510(K) Exempt
CFR Regulation Number880.5630 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeNTX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2700
DeviceNursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (f-68)
Product CodeNTX
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionNipple Shield.
CFR Regulation Number880.5630 [🔎]
TPLC Last Update: 2019-04-02 20:17:35

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