GUDIDData
gudid Primary ID: 12881-22

Oval Frame (UDI 12881-22)

Manufactured by SONTEC INSTRUMENTS, INC.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Oval Frame - Primary ID 12881-22

Device Regulatory Overview

The Oval Frame (Model/Catalog Number: 12881-22) is a medical device manufactured by SONTEC INSTRUMENTS, INC.. This product is indexed under FDA Product Code / Category Classification FFO within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
12881-22
Product Code / EMDN
FFO
Device Name
Oval Frame Only For Dufner Thoracic and Abdominal Retractor
Database Sync Date
2026-08-09 09:07:00

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 Oval Frame?

The registered manufacturer of record for Oval Frame is SONTEC INSTRUMENTS, INC..

What is the Primary UDI-DI identifier for Oval Frame?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 12881-22.

What classification code is assigned to this device?

This device is registered under product classification code FFO.

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