GUDIDData
gudid Primary ID: DP35-0215-102

8mm Cryoprobe (UDI DP35-0215-102)

Manufactured by Varian Medical Systems, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for 8mm Cryoprobe - Primary ID DP35-0215-102

Device Regulatory Overview

The 8mm Cryoprobe (Model/Catalog Number: DP35-0215-102) is a medical device manufactured by Varian Medical Systems, Inc.. This product is indexed under FDA Product Code / Category Classification OCL 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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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...

🔒 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...

🔒 Compromised Lot & Serial Numbers Locked
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Technical Specifications

Model Number
DP35-0215-102
Product Code / EMDN
OCL
Device Name
Straight 8mm cryoprobefor use with Cryocare systems (Lead-Free)
Database Sync Date
2026-08-09 09:22:18

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 8mm Cryoprobe?

The registered manufacturer of record for 8mm Cryoprobe is Varian Medical Systems, Inc..

What is the Primary UDI-DI identifier for 8mm Cryoprobe?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is DP35-0215-102.

What classification code is assigned to this device?

This device is registered under product classification code OCL.

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