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eudamed_udi Primary ID: 00810563022063

2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, Spherical (UDI 00810563022063)

Manufactured by Varian Medical Systems, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, Spherical - Primary ID 00810563022063

Device Regulatory Overview

The 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, Spherical (Model/Catalog Number: PC-2.1SL) is a medical device manufactured by Varian Medical Systems, Inc.. This product is indexed under FDA Product Code / Category Classification Z120102 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-0990-2017 View Full Alert →

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πŸ”’ Compromised Lot & Serial Numbers Locked
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ID: Z-0760-2013 View Full Alert →

Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachyth...

πŸ”’ Compromised Lot & Serial Numbers Locked
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ID: Z-1324-2013 View Full Alert →

Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed do...

πŸ”’ Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
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Technical Specifications

Model Number
PC-2.1SL
Product Code / EMDN
Z120102
Device Name
ISOLIS Cryoprobe
Database Sync Date
2026-08-09 16:48:39

Full Regulatory Attributes

πŸ”’ 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 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, Spherical?

The registered manufacturer of record for 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, Spherical is Varian Medical Systems, Inc..

What is the Primary UDI-DI identifier for 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, Spherical?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00810563022063.

What classification code is assigned to this device?

This device is registered under product classification code Z120102.

Similar Classification Devices (Z120102)

Other Devices by Varian Medical Systems, Inc.

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