eudamed_udi
Primary ID: 20884521185972
VersaOne™ (UDI 20884521185972)
Manufactured by Covidien llc
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for VersaOne™ - Primary ID 20884521185972
Device Regulatory Overview
The VersaOne™ (Model/Catalog Number: ONB15STF) is a medical device manufactured by Covidien llc. This product is indexed under FDA Product Code / Category Classification K01010103 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- ONB15STF
- Product Code / EMDN
- K01010103
- Device Name
- VersaOne™ Universal Fixation Balloon
- Database Sync Date
- 2026-08-09 16:29:57
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 VersaOne™?
The registered manufacturer of record for VersaOne™ is Covidien llc.
What is the Primary UDI-DI identifier for VersaOne™?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 20884521185972.
What classification code is assigned to this device?
This device is registered under product classification code K01010103.
Similar Classification Devices (K01010103)
Other Devices by Covidien llc
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