OGU

Pierced Ear/Entry Cleaning Tray

Product code

OGU

Device name

Pierced Ear/Entry Cleaning Tray

Device class

Class 1

21 CFR

21 CFR 874.4420

Medical specialty

Ear, Nose, Throat

Marketing pathway

Enforcement Discretion

FDA classification definition

Contents typically includes: Ear piercing instrument, alcohol prep pads (pro code: LKB - unclassified), ear piercing studs. 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).