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Richline Group, Inc. d/b/a Inverness

Richline Group, Inc. · Model Version 0 · UDI-DI 00860014537103

JYS

510(k) clearances

393

Adverse events

Recalls

Facilities

Description

The Inverness 2000 Ear Piercing Earring provides a means for safe and reliable ear piercing. The product includes a reusable or single Ear Piercing instrument which holds an integrated disposable cartridge. The integrated cartridge houses both a piercing earring within a disposable protective capsule and a fully enclosed safety clutch. Hand pressure activation of the instrument advances the capsule from the cartridge to the ear lobe. Further hand pressure advances the piercing posted earring from the capsule, through the ear and into a fully enclosed safety clutch. The earring is released from the capsule as the earring decorative element passes through and breaks the capsule retention webs. The clutch is released as the post tip displaces the clutch and a clutch retention finger. A lidded cassette houses and protects the sterility of two cartridges and contents prior to use.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.