gudid
Primary ID: UC38
BioSonic (UDI UC38)
Manufactured by COLTENE/WHALEDENT INC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for BioSonic - Primary ID UC38
Device Regulatory Overview
The BioSonic (Model/Catalog Number: UC38) is a medical device manufactured by COLTENE/WHALEDENT INC. This product is indexed under FDA Product Code / Category Classification FLG within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- UC38
- Product Code / EMDN
- FLG
- Device Name
- Germicidal Solution - 8 oz
- Database Sync Date
- 2026-08-09 09:03:05
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 BioSonic?
The registered manufacturer of record for BioSonic is COLTENE/WHALEDENT INC.
What is the Primary UDI-DI identifier for BioSonic?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is UC38.
What classification code is assigned to this device?
This device is registered under product classification code FLG.
Similar Classification Devices (FLG)
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