gudid
Primary ID: E3146US
OSSEOUS Silicone Sheets (UDI E3146US)
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 E3146US
Device Regulatory Overview
The OSSEOUS Silicone Sheets (Model/Catalog Number: E3146US) 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
- E3146US
- 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
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)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 E3146US.
What classification code is assigned to this device?
This device is registered under product classification code EPP.
Similar Classification Devices (EPP)
Other Devices by EON MEDITECH PRIVATE LIMITED
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint