GUDIDData
gudid Primary ID: E3146T

OSSEOUS Silicone Sheets (UDI E3146T)

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 Silicone Sheets - Primary ID E3146T

Device Regulatory Overview

The OSSEOUS Silicone Sheets (Model/Catalog Number: E3146T) 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
E3146T
Product Code / EMDN
EPP
Device Name
"Internal Nasal Splint enhances patient comfort by Allowing nasal breathing while providing support of nasal Septal structure."
Database Sync Date
2026-08-09 09:29:37

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 Silicone Sheets?

The registered manufacturer of record for OSSEOUS Silicone Sheets is EON MEDITECH PRIVATE LIMITED.

What is the Primary UDI-DI identifier for OSSEOUS Silicone Sheets?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is E3146T.

What classification code is assigned to this device?

This device is registered under product classification code EPP.

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