Definition: A NURSING PAD CONSISTING OF A POLYURETHANE PAD WITH GLYCERIN USED TO RELIEVE NIPPLES THAT ARE SORE AND CRACKED FROM BREASTFEEDING.
Device Type ID | 2700 |
Device Name | Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (f-68) |
Regulation Description | Nipple Shield. |
Regulation Medical Specialty | General Hospital |
Review Panel | General 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 Type | 510(K) Exempt |
CFR Regulation Number | 880.5630 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | NTX |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2700 |
Device | Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (f-68) |
Product Code | NTX |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Nipple Shield. |
CFR Regulation Number | 880.5630 [🔎] |