FDA product code QGJ

Corneal Inlay Inserter Handle

Ophthalmic·Class 1·21 CFR 886.4355
US regulatory classifications
US Product Code (FDA)
QGJ
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 886.4355
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Medical specialty
Ophthalmic
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

The corneal inlay inserter handle is a hand-held device intended to be used as an accessory to a corneal inlay inserter. The device extends the length of the inlay inserter to aid in delivering the inlay implant.

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About this record

Corneal Inlay Inserter Handle 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.