Single Use Instrument Tray
The Single Use Instrument Tray is a convenience kit containing single-use surgical instruments packaged as a ready-to-use set for a specific procedure or procedural step, intended to eliminate reprocessing and reduce infection risk. Classified as FDA Class 1 under regulation 21 CFR 878.4800 within the General, Plastic Surgery medical specialty, it is under enforcement discretion per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance and does not require a 510(k) when all criteria are met. The product code is OJV. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OJV
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 7
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
FEI Numbers
This FDA classification entry is associated with 39 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 39 registration numbers. Click on an entry to view related FDA registrations.