FDA product code NOD: Board, Arm (With Cover), Non-Sterile

NOD is the FDA product code for board, arm (with cover), non-sterile. It is a Class I device, regulated under 21 CFR 878.3910 and reviewed by the General and Plastic Surgery panel. Devices under NOD reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.

Classification

FieldValue
Device nameBoard, Arm (With Cover), Non-Sterile
Device classClass I
Regulation21 CFR 878.3910
Review panelSU — General and Plastic Surgery
Medical specialtyGeneral, Plastic Surgery
Premarket route510(k) exempt
GMP exemptYes

Recalls for NOD devices

openFDA lists no recalls for product code NOD.

Frequently asked questions

What is FDA product code NOD?

NOD is the FDA product code for board, arm (with cover), non-sterile. It is a Class I device, regulated under 21 CFR 878.3910 and reviewed by the General and Plastic Surgery panel.

What device class is NOD?

Class I, regulation 21 CFR 878.3910. Typical premarket route: 510(k) exempt.

Next steps

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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