Nursing Pad, Hydrogel

Device Code: 2699

Product Code(s): NTC

Device Classification Information

Device Type ID2699
Device NameNursing Pad, Hydrogel
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 CodeNTC
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2699
DeviceNursing Pad, Hydrogel
Product CodeNTC
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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