FDA product code OJI: Burn Kit With Drug
OJI is the FDA product code for burn kit with drug. It is a Not classified device, reviewed by the General and Plastic Surgery panel. Devices under OJI reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Burn Kit With Drug |
| Device class | Not classified |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for OJI devices
openFDA lists no recalls for product code OJI.
Frequently asked questions
What is FDA product code OJI?
OJI is the FDA product code for burn kit with drug. It is a Not classified device, reviewed by the General and Plastic Surgery panel.
What device class is OJI?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code OJI
- Run a recall and safety report across every OJI manufacturer
- Watch product code OJI for new clearances and recalls
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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