GUDIDData
gudid Primary ID: 305810-0108-810

Sterilizable sleeve (UDI 305810-0108-810)

Manufactured by Carl Zeiss Meditec AG

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Sterilizable sleeve - Primary ID 305810-0108-810

Device Regulatory Overview

The Sterilizable sleeve (Model/Catalog Number: 305810-0108-810) is a medical device manufactured by Carl Zeiss Meditec AG. This product is indexed under FDA Product Code / Category Classification PUI 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-2649-2026 View Full Alert →

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ID: Z-1153-2014 View Full Alert →

Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser K...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-1049-2015 View Full Alert →

FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format). Catalog numbers: 00000...

🔒 Compromised Lot & Serial Numbers Locked
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Technical Specifications

Model Number
305810-0108-810
Product Code / EMDN
PUI
Device Name
Database Sync Date
2026-08-09 09:11:22

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 Sterilizable sleeve?

The registered manufacturer of record for Sterilizable sleeve is Carl Zeiss Meditec AG.

What is the Primary UDI-DI identifier for Sterilizable sleeve?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 305810-0108-810.

What classification code is assigned to this device?

This device is registered under product classification code PUI.

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