gudid Primary ID: 75.70.057

Positioning handle - M8x1 interface (UDI 75.70.057)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Positioning handle - M8x1 interface (Model/Catalog Number: 75.70.057) is a medical device manufactured by Incipio Devices SA. This product is indexed under FDA Product Code / Category Classification HWA within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 75.70.057
Product Code / EMDN: HWA
Device Name: Positioning handle assembly accessory for offset cup impactor M8x1 interface
Database Sync Date: 2026-08-09 09:03:20

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 Positioning handle - M8x1 interface?

The registered manufacturer of record for Positioning handle - M8x1 interface is Incipio Devices SA.

What is the Primary UDI-DI identifier for Positioning handle - M8x1 interface?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 75.70.057.

What classification code is assigned to this device?

This device is registered under product classification code HWA.

Similar Classification Devices (HWA)

Other Devices by Incipio Devices SA

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