OII

Arthrogram Tray

Product code

OII

Device name

Arthrogram Tray

Device class

Class 2

21 CFR

21 CFR 892.1650

Medical specialty

Radiology

Marketing pathway

510(K) Exempt

FDA classification definition

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).