eudamed_udi Primary ID: 00385640047340

InstruSafe (UDI 00385640047340)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The InstruSafe (Model/Catalog Number: IN-2020-3639) is a medical device manufactured by Summit Medical, LLC. This product is indexed under FDA Product Code / Category Classification V0402 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: IN-2020-3639
Product Code / EMDN: V0402
Device Name: InstruSafe Instrument Protection System - Trays, Accessories, and Transport Containers
Database Sync Date: 2026-08-09 16:28:50

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 InstruSafe?

The registered manufacturer of record for InstruSafe is Summit Medical, LLC.

What is the Primary UDI-DI identifier for InstruSafe?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00385640047340.

What classification code is assigned to this device?

This device is registered under product classification code V0402.

Similar Classification Devices (V0402)

Other Devices by Summit Medical, LLC

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