GUDIDData
eudamed_udi Primary ID: 00850038669096

38K (UDI 00850038669096)

Manufactured by IC Biomedical, LLC

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for 38K - Primary ID 00850038669096

Device Regulatory Overview

The 38K (Model/Catalog Number: 38K) is a medical device manufactured by IC Biomedical, LLC. This product is indexed under FDA Product Code / Category Classification W020702 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
38K
Product Code / EMDN
W020702
Device Name
K Series Cryostorage Systems
Database Sync Date
2026-08-09 18:59:02

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 38K?

The registered manufacturer of record for 38K is IC Biomedical, LLC.

What is the Primary UDI-DI identifier for 38K?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00850038669096.

What classification code is assigned to this device?

This device is registered under product classification code W020702.

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