GUDIDData
gudid Primary ID: 40-422-USA

EYETEC (UDI 40-422-USA)

Manufactured by Summit Medical, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for EYETEC - Primary ID 40-422-USA

Device Regulatory Overview

The EYETEC (Model/Catalog Number: 40-422-USA) is a medical device manufactured by Summit Medical, Inc.. This product is indexed under FDA Product Code / Category Classification HOZ 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-1319-2013 View Full Alert →

Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 Northwest Parkway, Suite 100, St. Paul, MN...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-0435-2016 View Full Alert →

AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx...

🔒 Compromised Lot & Serial Numbers Locked
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Unlock Lot Data ($49)
ID: Z-1731-2014 View Full Alert →

Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only. Intended to provi...

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

Model Number
40-422-USA
Product Code / EMDN
HOZ
Device Name
Corneal Light Shield 9mm
Database Sync Date
2026-08-09 09:57:36

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 EYETEC?

The registered manufacturer of record for EYETEC is Summit Medical, Inc..

What is the Primary UDI-DI identifier for EYETEC?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 40-422-USA.

What classification code is assigned to this device?

This device is registered under product classification code HOZ.

Programmatic Export

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