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Novo Surgical Inc.

NOVO SURGICAL, INC. · Model E95662-13 · UDI-DI 00842331179846

KBN Prescription
3
510(k) clearances
47
Adverse events
1
Recalls
212
Facilities

Description

zenith davis mouth gag, 6 1/4" (15.9 cm), complete set includes right frame (E5662-32) & 5 blades (E5662-22, E5662-23, E5662-24, E5662-25, E5662-26)

Recalls

DateFirmReason
2018-02-16Aesculap Implant Systems LLCThe plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.

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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.