gudid
Primary ID: Z8411
HardyDisk (UDI Z8411)
Manufactured by HARDY DIAGNOSTICS
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for HardyDisk - Primary ID Z8411
Device Regulatory Overview
The HardyDisk (Model/Catalog Number: Z8411) is a medical device manufactured by HARDY DIAGNOSTICS. This product is indexed under FDA Product Code / Category Classification JTO within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- Z8411
- Product Code / EMDN
- JTO
- Device Name
- Colistin, 10mcg, CT, for the differentiation of anaerobic bacteria based on susceptibility to Colistin, 1 x 50 disks, used as an aid in clarifying gramstain reaction of anaerobes, and in preliminary grouping of anaerobic gram-negative bacilli.
- Database Sync Date
- 2026-08-09 09:31:30
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of HardyDisk?
The registered manufacturer of record for HardyDisk is HARDY DIAGNOSTICS.
What is the Primary UDI-DI identifier for HardyDisk?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z8411.
What classification code is assigned to this device?
This device is registered under product classification code JTO.
Similar Classification Devices (JTO)
Other Devices by HARDY DIAGNOSTICS
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