GUDIDData
gudid Primary ID: SP-27247

27247 (UDI SP-27247)

Manufactured by Bionix, LLC

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for 27247 - Primary ID SP-27247

Device Regulatory Overview

The 27247 (Model/Catalog Number: SP-27247) is a medical device manufactured by Bionix, LLC. This product is indexed under FDA Product Code / Category Classification LRD within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
SP-27247
Product Code / EMDN
LRD
Device Name
Sample, OtoClear Ear Irrigation System (220V)
Database Sync Date
2026-08-09 09:04:11

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 27247?

The registered manufacturer of record for 27247 is Bionix, LLC.

What is the Primary UDI-DI identifier for 27247?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is SP-27247.

What classification code is assigned to this device?

This device is registered under product classification code LRD.

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