Tuttnauer (UDI WTL198-0067)
Manufactured by TERRAGENE S.A.
Device Regulatory Overview
The Tuttnauer (Model/Catalog Number: WTL198-0067) is a medical device manufactured by TERRAGENE S.A.. This product is indexed under FDA Product Code / Category Classification FRC within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- WTL198-0067
- Product Code / EMDN
- FRC
- Device Name
- Self-contained Biological Indicator for monitoring hydrogen peroxide sterilization processes
- Database Sync Date
- 2026-08-09 09:07:23
Full Regulatory Attributes
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{
"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 Tuttnauer?
The registered manufacturer of record for Tuttnauer is TERRAGENE S.A..
What is the Primary UDI-DI identifier for Tuttnauer?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is WTL198-0067.
What classification code is assigned to this device?
This device is registered under product classification code FRC.
Similar Classification Devices (FRC)
Other Devices by TERRAGENE S.A.
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