GUDIDData
eudamed_udi Primary ID: 10845854020593

ULTRABLATOR (UDI 10845854020593)

Manufactured by Conmed Corporation

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ULTRABLATOR - Primary ID 10845854020593

Device Regulatory Overview

The ULTRABLATOR (Model/Catalog Number: ESA-5234) is a medical device manufactured by Conmed Corporation. This product is indexed under FDA Product Code / Category Classification K02030101 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-2597-2016 View Full Alert →

Pediatric ThermoGard Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710. Intended to be used f...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-2599-2016 View Full Alert →

Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
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ID: Z-2598-2016 View Full Alert →

Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, ...

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

Technical Specifications

Model Number
ESA-5234
Product Code / EMDN
K02030101
Device Name
Orthopedic, Active, Instrument, Electrosurgical, Monopolar, Electrode
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 ULTRABLATOR?

The registered manufacturer of record for ULTRABLATOR is Conmed Corporation.

What is the Primary UDI-DI identifier for ULTRABLATOR?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 10845854020593.

What classification code is assigned to this device?

This device is registered under product classification code K02030101.

Programmatic Export

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