GUDIDData
emdn_classification Primary ID: M9001

CRYOTHERAPY AND THERMOTHERAPY DEVICES (UDI M9001)

Manufactured by

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CRYOTHERAPY AND THERMOTHERAPY DEVICES - Primary ID M9001

Device Regulatory Overview

The CRYOTHERAPY AND THERMOTHERAPY DEVICES (Model/Catalog Number: Unspecified) is a medical device manufactured by . This product is indexed under FDA Product Code / Category Classification M9001 within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-2753-2026 View Full Alert →

FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-2755-2026 View Full Alert →

FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, I...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
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ID: Z-2793-2026 View Full Alert →

SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
N/A
Product Code / EMDN
M9001
Device Name
CRYOTHERAPY AND THERMOTHERAPY DEVICES
Database Sync Date
2026-08-09 16:18:37

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 CRYOTHERAPY AND THERMOTHERAPY DEVICES?

The registered manufacturer of record for CRYOTHERAPY AND THERMOTHERAPY DEVICES is .

What is the Primary UDI-DI identifier for CRYOTHERAPY AND THERMOTHERAPY DEVICES?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is M9001.

What classification code is assigned to this device?

This device is registered under product classification code M9001.

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint