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OGUClass I

Pierced Ear/Entry Cleaning Tray

21 CFR 874.4420 / Ear, Nose, Throat
FDA source (opens on fda.gov)

OGU is the FDA product code for Pierced Ear/Entry Cleaning Tray, a class I device type, regulated under 21 CFR 874.4420. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
OGU
Device name
Pierced Ear/Entry Cleaning Tray
FDA 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.
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Submission type
FDA code 7
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code