Tools For Surgery, LLCNovember 6, 2025

FDA 483 - Tools For Surgery, LLC - November 06, 2025

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Record Details

An FDA inspection of Tools For Surgery, LLC in Stony Brook, NY on November 6, 2025, revealed one observation. The firm failed to provide required information for their ZZIRÉN® OROGASTRIC TUBE to the Global Unique Device Identification Database. This indicates a lapse in regulatory compliance for medical device identification.

Company: Tools For Surgery, LLC
Inspection Date: November 6, 2025
Product Type: Device
Office: Division of Human and Animal Food Operations - East I
Person: Preston M. Lee

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ID · 7a8c7dc2-7c2b-4a65-8591-71c437b19b6b