GUDIDData
eudamed_udi Primary ID: 05051986001562

5-12 Single Use Universal Seal (UDI 05051986001562)

Manufactured by Surgical Innovations Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for 5-12 Single Use Universal Seal - Primary ID 05051986001562

Device Regulatory Overview

The 5-12 Single Use Universal Seal (Model/Catalog Number: EA512US) is a medical device manufactured by Surgical Innovations Ltd.. This product is indexed under FDA Product Code / Category Classification K01020110 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
EA512US
Product Code / EMDN
K01020110
Device Name
Single use Seal / Valve
Database Sync Date
2026-08-09 17:13:34

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of 5-12 Single Use Universal Seal?

The registered manufacturer of record for 5-12 Single Use Universal Seal is Surgical Innovations Ltd..

What is the Primary UDI-DI identifier for 5-12 Single Use Universal Seal?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05051986001562.

What classification code is assigned to this device?

This device is registered under product classification code K01020110.

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint