Burn Kit With Drug
The Burn Kit With Drug is a convenience kit containing components for the treatment of burn wounds, which includes an incorporated drug product as part of the kit. It carries an FDA device class designation of "N" (not classified/not a device) because the combination product's drug component changes its regulatory pathway; the kit is reviewed by the General, Plastic Surgery panel. It falls under enforcement discretion per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance. The product code is OJI. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OJI
- Device Class
- FDA not classified
- Medical Specialty
- Unknown
- Review Panel
- SU
- Submission Type
- 3
Device Characteristics
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.
Unclassified Reason
6
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.