gudid Primary ID: 3629-03/Y

Formed Irrigating Cystotomes (UDI 3629-03/Y)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Formed Irrigating Cystotomes (Model/Catalog Number: 3629-03/Y) is a medical device manufactured by STERIMEDIX LIMITED. This product is indexed under FDA Product Code / Category Classification MED within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 3629-03/Y
Product Code / EMDN: MED
Device Name: 25g Irrig Cyst Rev Fmd
Database Sync Date: 2026-08-09 09:08:14

Full Regulatory Attributes

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{
    "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 Formed Irrigating Cystotomes?

The registered manufacturer of record for Formed Irrigating Cystotomes is STERIMEDIX LIMITED.

What is the Primary UDI-DI identifier for Formed Irrigating Cystotomes?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 3629-03/Y.

What classification code is assigned to this device?

This device is registered under product classification code MED.

Similar Classification Devices (MED)

Other Devices by STERIMEDIX LIMITED

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