GUDIDData
gudid Primary ID: MSC-FM-R

BMI (UDI MSC-FM-R)

Manufactured by Blake Manufacturing, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for BMI - Primary ID MSC-FM-R

Device Regulatory Overview

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

Technical Specifications

Model Number
MSC-FM-R
Product Code / EMDN
ILH
Device Name
Hyper Extension Mitt orthosis, size Regular
Database Sync Date
2026-08-09 09:04:02

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 BMI?

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

What is the Primary UDI-DI identifier for BMI?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is MSC-FM-R.

What classification code is assigned to this device?

This device is registered under product classification code ILH.

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