GUDIDData
eudamed_udi Primary ID: 05708012000975

OneWayGlide (UDI 05708012000975)

Manufactured by Etac Immedia A/S

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for OneWayGlide - Primary ID 05708012000975

Device Regulatory Overview

The OneWayGlide (Model/Catalog Number: IM51/8) is a medical device manufactured by Etac Immedia A/S. This product is indexed under FDA Product Code / Category Classification V080399 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
IM51/8
Product Code / EMDN
V080399
Device Name
OneWayGlide
Database Sync Date
2026-08-09 16:28:44

Full Regulatory Attributes

🔒 Token Gated
{
    "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 OneWayGlide?

The registered manufacturer of record for OneWayGlide is Etac Immedia A/S.

What is the Primary UDI-DI identifier for OneWayGlide?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05708012000975.

What classification code is assigned to this device?

This device is registered under product classification code V080399.

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