gudid Primary ID: DS-AFO-R-SB

Panacea (UDI DS-AFO-R-SB)

Manufactured by Blake Manufacturing, Inc.

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Panacea (Model/Catalog Number: DS-AFO-R-SB) is a medical device manufactured by Blake Manufacturing, Inc.. This product is indexed under FDA Product Code / Category Classification ITW within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: DS-AFO-R-SB
Product Code / EMDN: ITW
Device Name: Panacea Shortback Ankle Foot Orthosis, size Regular
Database Sync Date: 2026-08-09 09:04:02

Full Regulatory Attributes

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{
    "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 Panacea?

The registered manufacturer of record for Panacea is Blake Manufacturing, Inc..

What is the Primary UDI-DI identifier for Panacea?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is DS-AFO-R-SB.

What classification code is assigned to this device?

This device is registered under product classification code ITW.

Similar Classification Devices (ITW)

Other Devices by Blake Manufacturing, Inc.

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