GUDIDData
eudamed_udi Primary ID: 08682431302278

Oltho (UDI 08682431302278)

Manufactured by SELES SAGLIK HIZMETLERI IMALAT OTO KIR.INS.SAN.TIC.A.S.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Oltho - Primary ID 08682431302278

Device Regulatory Overview

The Oltho (Model/Catalog Number: S00227) is a medical device manufactured by SELES SAGLIK HIZMETLERI IMALAT OTO KIR.INS.SAN.TIC.A.S.. This product is indexed under FDA Product Code / Category Classification P09120503 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
S00227
Product Code / EMDN
P09120503
Device Name
Oltho Cannulated Locking Screw, Self Threaded 3.5mm x 22mm
Database Sync Date
2026-08-09 16:28:44

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 Oltho?

The registered manufacturer of record for Oltho is SELES SAGLIK HIZMETLERI IMALAT OTO KIR.INS.SAN.TIC.A.S..

What is the Primary UDI-DI identifier for Oltho?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08682431302278.

What classification code is assigned to this device?

This device is registered under product classification code P09120503.

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