Product code

HJB: Instrument, measuring, corneal radius

FDA product code · Class I · Ophthalmic

Key facts

Product code HJB
Device Instrument, measuring, corneal radius
Device class Class I
Regulation number 886.1450
Review panel Ophthalmic
Medical specialty Ophthalmic
Submission type 510(K) Exempt
GMP exempt No
Implanted device No
Life-sustaining or life-supporting No

At a glance

  • 1–9 510(k) clearances
  • None De Novo grants
  • None PMA approvals
  • None HDE approvals
  • 10–99 UDI devices (GUDID)
  • 10–99 MAUDE adverse event reports
  • 1–9 Recalled products (Z-numbers)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device product codes

FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.

Source: U.S. Food and Drug Administration (FDA), Product Classification database

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