FDA product code OHW

Burr, Corneal, Battery Powered, Rust Ring Removal

Ophthalmic·Class 1·21 CFR 886.4070
US regulatory classifications
US Product Code (FDA)
OHW
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 886.4070
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Medical specialty
Ophthalmic
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye and is class I exempt when intended only for rust ring removal.

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About this record

Burr, Corneal, Battery Powered, Rust Ring Removal is a medical device type in the Ophthalmic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.