eudamed_udi Primary ID: 00385640001670

Straight Shank, FP, 1.14 mm (UDI 00385640001670)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Straight Shank, FP, 1.14 mm (Model/Catalog Number: VT-0901-01) is a medical device manufactured by Summit Medical, LLC. This product is indexed under FDA Product Code / Category Classification Q03040199 within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 1 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-1171-2023 View Full Alert →

Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile....

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Technical Specifications

Model Number: VT-0901-01
Product Code / EMDN: Q03040199
Device Name: Otological Ventilation Tubes
Database Sync Date: 2026-08-09 16:46:06

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of Straight Shank, FP, 1.14 mm?

The registered manufacturer of record for Straight Shank, FP, 1.14 mm is Summit Medical, LLC.

What is the Primary UDI-DI identifier for Straight Shank, FP, 1.14 mm?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00385640001670.

What classification code is assigned to this device?

This device is registered under product classification code Q03040199.

Similar Classification Devices (Q03040199)

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