gudid
Primary ID: OTU-OM100R
WiScope (UDI OTU-OM100R)
Manufactured by Otu Medical Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for WiScope - Primary ID OTU-OM100R
Device Regulatory Overview
The WiScope (Model/Catalog Number: OTU-OM100R) is a medical device manufactured by Otu Medical Inc.. This product is indexed under FDA Product Code / Category Classification FGB within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- OTU-OM100R
- Product Code / EMDN
- FGB
- Device Name
- Single-Use Digital Flexible Ureteroscope/Choledochoscope
- Database Sync Date
- 2026-08-09 09:00:28
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 WiScope?
The registered manufacturer of record for WiScope is Otu Medical Inc..
What is the Primary UDI-DI identifier for WiScope?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is OTU-OM100R.
What classification code is assigned to this device?
This device is registered under product classification code FGB.
Similar Classification Devices (FGB)
Other Devices by Otu Medical Inc.
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