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Renú Gel

CYTOPHIL, INC. · Model 08-015-00-V04 · UDI-DI 00856509002935

MIX Prescription
10
510(k) clearances
41
Adverse events
1
Recalls
10
Facilities

Description

Renú Gel Vocal Fold Implant is a sterile, semi-solid, cohesive implant indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue-bulking agent.

Recalls

DateFirmReason
2015-10-26Merz North America, Inc.The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.

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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.