GUDIDData
eudamed_udi Primary ID: 00194545161866

MapleLeaf Hip Orthosis - Modular HIP M THIGH XS (UDI 00194545161866)

Manufactured by Becker Orthopedic Appliance Company

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for MapleLeaf Hip Orthosis - Modular HIP M THIGH XS - Primary ID 00194545161866

Device Regulatory Overview

The MapleLeaf Hip Orthosis - Modular HIP M THIGH XS (Model/Catalog Number: 147-MOD-M-XS) is a medical device manufactured by Becker Orthopedic Appliance Company. This product is indexed under FDA Product Code / Category Classification Y061215 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
147-MOD-M-XS
Product Code / EMDN
Y061215
Device Name
Maple Leaf Orthosis
Database Sync Date
2026-08-09 16:29:38

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 MapleLeaf Hip Orthosis - Modular HIP M THIGH XS?

The registered manufacturer of record for MapleLeaf Hip Orthosis - Modular HIP M THIGH XS is Becker Orthopedic Appliance Company.

What is the Primary UDI-DI identifier for MapleLeaf Hip Orthosis - Modular HIP M THIGH XS?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00194545161866.

What classification code is assigned to this device?

This device is registered under product classification code Y061215.

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