PathBuilder Transseptal Guiding Introducer (UDI TSR0638)
Manufactured by Shanghai Microport Ep Medtech Co., Ltd.
Device Regulatory Overview
The PathBuilder Transseptal Guiding Introducer (Model/Catalog Number: TSR0638) is a medical device manufactured by Shanghai Microport Ep Medtech Co., Ltd.. This product is indexed under FDA Product Code / Category Classification DYB within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- TSR0638
- Product Code / EMDN
- DYB
- Device Name
- Database Sync Date
- 2026-08-09 09:05:25
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 PathBuilder Transseptal Guiding Introducer?
The registered manufacturer of record for PathBuilder Transseptal Guiding Introducer is Shanghai Microport Ep Medtech Co., Ltd..
What is the Primary UDI-DI identifier for PathBuilder Transseptal Guiding Introducer?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is TSR0638.
What classification code is assigned to this device?
This device is registered under product classification code DYB.
Similar Classification Devices (DYB)
Other Devices by Shanghai Microport Ep Medtech Co., Ltd.
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