GUDIDData
gudid Primary ID: 0009800131

HemosIL Acustar HIT Controls (UDI 0009800131)

Manufactured by INSTRUMENTATION LABORATORY COMPANY

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for HemosIL Acustar HIT Controls - Primary ID 0009800131

Device Regulatory Overview

The HemosIL Acustar HIT Controls (Model/Catalog Number: 0009800131) is a medical device manufactured by INSTRUMENTATION LABORATORY COMPANY. This product is indexed under FDA Product Code / Category Classification GGN within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
0009800131
Product Code / EMDN
GGN
Device Name
1. Low HIT Control (Cat. No. 00009800132)2. High HIT Control (Cat. No. 00009800133):
Database Sync Date
2026-08-09 09:10:49

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 HemosIL Acustar HIT Controls?

The registered manufacturer of record for HemosIL Acustar HIT Controls is INSTRUMENTATION LABORATORY COMPANY.

What is the Primary UDI-DI identifier for HemosIL Acustar HIT Controls?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 0009800131.

What classification code is assigned to this device?

This device is registered under product classification code GGN.

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