gudid Primary ID: Cottle septum speculum

Ambler Surgical (UDI Cottle septum speculum)

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

Scannable UDI-DI Representation

Device Regulatory Overview

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

Technical Specifications

Model Number: Cottle septum speculum
Product Code / EMDN: EPY
Device Name: Cottle septum speculum, 5 1/2'', narrow, 30.0mm long, tapered 9mm to 4mm wide blades, with set screw
Database Sync Date: 2026-08-09 09:01:45

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 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 Cottle septum speculum.

What classification code is assigned to this device?

This device is registered under product classification code EPY.

Similar Classification Devices (EPY)

Other Devices by AMBLER SURGICAL CORP.

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