gudid Primary ID: DMEK donor button marker

Ambler Surgical (UDI DMEK donor button marker)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Ambler Surgical (Model/Catalog Number: DMEK donor button marker) is a medical device manufactured by AMBLER SURGICAL CORP.. This product is indexed under FDA Product Code / Category Classification HMR within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: DMEK donor button marker
Product Code / EMDN: HMR
Device Name: DMEK donor button marker, angled shaft, designed to mark a mini reverse ''S'' pattern on the donor button, round handle
Database Sync Date: 2026-08-09 09:01:43

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 Ambler Surgical?

The registered manufacturer of record for Ambler Surgical is AMBLER SURGICAL CORP..

What is the Primary UDI-DI identifier for Ambler Surgical?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is DMEK donor button marker.

What classification code is assigned to this device?

This device is registered under product classification code HMR.

Similar Classification Devices (HMR)

Other Devices by AMBLER SURGICAL CORP.

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