GUDIDData
eudamed_udi Primary ID: 06971244543544

SIMPLE Shoulder Brace E18 (UDI 06971244543544)

Manufactured by Simple Medical (Shenzhen) Limited

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for SIMPLE Shoulder Brace E18 - Primary ID 06971244543544

Device Regulatory Overview

The SIMPLE Shoulder Brace E18 (Model/Catalog Number: 31012-F) is a medical device manufactured by Simple Medical (Shenzhen) Limited. This product is indexed under FDA Product Code / Category Classification Y060624 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
31012-F
Product Code / EMDN
Y060624
Device Name
SIMPLE Shoulder Abduction Immobilizer E6, CryoTreat Shoulder, SIMPLE Arm Sling E3, SIMPLE Multi-functional Arm Sling E4, SIMPLE Shoulder Brace E8, SIMPLE Arm Sling Shoulder Brace E5,SIMPLE Arm Sling Shoulder Brace E16,SIMPLE Arm Sling Shoulder Brace E17
Database Sync Date
2026-08-09 16:29:50

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 SIMPLE Shoulder Brace E18?

The registered manufacturer of record for SIMPLE Shoulder Brace E18 is Simple Medical (Shenzhen) Limited.

What is the Primary UDI-DI identifier for SIMPLE Shoulder Brace E18?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06971244543544.

What classification code is assigned to this device?

This device is registered under product classification code Y060624.

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