GUDIDData
eudamed_udi Primary ID: 00810050251549

Maramed Wrist Hand Orthosis, Large, Left (UDI 00810050251549)

Manufactured by BioSculptor Corporation

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Maramed Wrist Hand Orthosis, Large, Left - Primary ID 00810050251549

Device Regulatory Overview

The Maramed Wrist Hand Orthosis, Large, Left (Model/Catalog Number: WH-300L) is a medical device manufactured by BioSculptor Corporation. This product is indexed under FDA Product Code / Category Classification Y060612 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
WH-300L
Product Code / EMDN
Y060612
Device Name
Maramed Wrist Hand Series Orthosis
Database Sync Date
2026-08-09 16:29:03

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 Maramed Wrist Hand Orthosis, Large, Left?

The registered manufacturer of record for Maramed Wrist Hand Orthosis, Large, Left is BioSculptor Corporation.

What is the Primary UDI-DI identifier for Maramed Wrist Hand Orthosis, Large, Left?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00810050251549.

What classification code is assigned to this device?

This device is registered under product classification code Y060612.

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