gudid
Primary ID: E5150K
OSSEOUS Thermoplastic Splint Kit (UDI E5150K)
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 Thermoplastic Splint Kit - Primary ID E5150K
Device Regulatory Overview
The OSSEOUS Thermoplastic Splint Kit (Model/Catalog Number: E5150K) 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
- E5150K
- Product Code / EMDN
- EPP
- Device Name
- External Thermoplastic Nasal Splint splinting of nasal dorsum after Rhinoplastly and 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 Thermoplastic Splint Kit?
The registered manufacturer of record for OSSEOUS Thermoplastic Splint Kit is EON MEDITECH PRIVATE LIMITED.
What is the Primary UDI-DI identifier for OSSEOUS Thermoplastic Splint Kit?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is E5150K.
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