gudid
Primary ID: U03B011028
Ureteral Access Sheath (UDI U03B011028)
Manufactured by Well Lead Medical Co.,Ltd
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Ureteral Access Sheath - Primary ID U03B011028
Device Regulatory Overview
The Ureteral Access Sheath (Model/Catalog Number: U03B011028) is a medical device manufactured by Well Lead Medical Co.,Ltd. This product is indexed under FDA Product Code / Category Classification FED within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- U03B011028
- Product Code / EMDN
- FED
- Device Name
- 10Fr28cm
- Database Sync Date
- 2026-08-09 09:04:58
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 Ureteral Access Sheath?
The registered manufacturer of record for Ureteral Access Sheath is Well Lead Medical Co.,Ltd.
What is the Primary UDI-DI identifier for Ureteral Access Sheath?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is U03B011028.
What classification code is assigned to this device?
This device is registered under product classification code FED.
Similar Classification Devices (FED)
Other Devices by Well Lead Medical Co.,Ltd
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