GUDIDData
emdn_classification Primary ID: M04040501

HYDROGEL DRESSINGS, NON-COMBINED (UDI M04040501)

Manufactured by

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for HYDROGEL DRESSINGS, NON-COMBINED - Primary ID M04040501

Device Regulatory Overview

The HYDROGEL DRESSINGS, NON-COMBINED (Model/Catalog Number: Unspecified) is a medical device manufactured by . This product is indexed under FDA Product Code / Category Classification M04040501 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
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
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.
Unlock Lot Data ($49)
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
M04040501
Device Name
HYDROGEL DRESSINGS, NON-COMBINED
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
}
                            

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of HYDROGEL DRESSINGS, NON-COMBINED?

The registered manufacturer of record for HYDROGEL DRESSINGS, NON-COMBINED is .

What is the Primary UDI-DI identifier for HYDROGEL DRESSINGS, NON-COMBINED?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is M04040501.

What classification code is assigned to this device?

This device is registered under product classification code M04040501.

Programmatic Export

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

JSON API Endpoint