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HomeSUGIH INSTRUMENDO ABADI, PT › ABN Deluxe Penlight

ABN Deluxe Penlight

SUGIH INSTRUMENDO ABADI, PT · Model PL-900-212 · UDI-DI 08997021263526

KYT
6
510(k) clearances
10
Adverse events
1
Recalls
159
Facilities

Description

ABN Deluxe Penlight is a medical device used as an assessment tool especially small body parts such as eyes, ears, nose, and mouth.

Recalls

DateFirmReason
2023-03-20DermLite LLCIncorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling.

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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.