GUDIDData
gudid Primary ID: E3146USF

OSSEOUS Fluoroplastic Sheet (UDI E3146USF)

Manufactured by EON MEDITECH PRIVATE LIMITED

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for OSSEOUS Fluoroplastic Sheet - Primary ID E3146USF

Device Regulatory Overview

The OSSEOUS Fluoroplastic Sheet (Model/Catalog Number: E3146USF) is a medical device manufactured by EON MEDITECH PRIVATE LIMITED. This product is indexed under FDA Product Code / Category Classification EPP within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
E3146USF
Product Code / EMDN
EPP
Device Name
Fluoroplastic Internal Nasal Splint enhances patient comfort by allowing nasal breathing while providing support of nasal septal structure.
Database Sync Date
2026-08-09 09:29:38

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 OSSEOUS Fluoroplastic Sheet?

The registered manufacturer of record for OSSEOUS Fluoroplastic Sheet is EON MEDITECH PRIVATE LIMITED.

What is the Primary UDI-DI identifier for OSSEOUS Fluoroplastic Sheet?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is E3146USF.

What classification code is assigned to this device?

This device is registered under product classification code EPP.

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