GUDIDData
eudamed_udi Primary ID: 00194545080624

Plastic Sternal Bar with U-Bracket, Large (UDI 00194545080624)

Manufactured by Becker Orthopedic Appliance Company

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Plastic Sternal Bar with U-Bracket, Large - Primary ID 00194545080624

Device Regulatory Overview

The Plastic Sternal Bar with U-Bracket, Large (Model/Catalog Number: 25-19-L) is a medical device manufactured by Becker Orthopedic Appliance Company. This product is indexed under FDA Product Code / Category Classification Y060309 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
25-19-L
Product Code / EMDN
Y060309
Device Name
Hyperextension TLSO w/Dot Fastener
Database Sync Date
2026-08-09 16:29:04

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 Plastic Sternal Bar with U-Bracket, Large?

The registered manufacturer of record for Plastic Sternal Bar with U-Bracket, Large is Becker Orthopedic Appliance Company.

What is the Primary UDI-DI identifier for Plastic Sternal Bar with U-Bracket, Large?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00194545080624.

What classification code is assigned to this device?

This device is registered under product classification code Y060309.

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