eudamed_udi
Primary ID: 00817688020622
Non-Telescopic PenEvac® (UDI 00817688020622)
Manufactured by I.C. Medical, Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Non-Telescopic PenEvac® - Primary ID 00817688020622
Device Regulatory Overview
The Non-Telescopic PenEvac® (Model/Catalog Number: ICM-000-0522) is a medical device manufactured by I.C. Medical, Inc.. This product is indexed under FDA Product Code / Category Classification K0201010501 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- ICM-000-0522
- Product Code / EMDN
- K0201010501
- Device Name
- PenEvac1
- Database Sync Date
- 2026-08-09 16:30:02
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 Non-Telescopic PenEvac®?
The registered manufacturer of record for Non-Telescopic PenEvac® is I.C. Medical, Inc..
What is the Primary UDI-DI identifier for Non-Telescopic PenEvac®?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00817688020622.
What classification code is assigned to this device?
This device is registered under product classification code K0201010501.
Similar Classification Devices (K0201010501)
Other Devices by I.C. Medical, Inc.
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint