gudid
Primary ID: 27295
OtoClear Spray Wash, Sample (UDI 27295)
Manufactured by Bionix, LLC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for OtoClear Spray Wash, Sample - Primary ID 27295
Device Regulatory Overview
The OtoClear Spray Wash, Sample (Model/Catalog Number: 27295) is a medical device manufactured by Bionix, LLC. This product is indexed under FDA Product Code / Category Classification KCP within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 27295
- Product Code / EMDN
- KCP
- Device Name
- Sample, Spraywash
- Database Sync Date
- 2026-08-09 09:04:11
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 OtoClear Spray Wash, Sample?
The registered manufacturer of record for OtoClear Spray Wash, Sample is Bionix, LLC.
What is the Primary UDI-DI identifier for OtoClear Spray Wash, Sample?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 27295.
What classification code is assigned to this device?
This device is registered under product classification code KCP.
Similar Classification Devices (KCP)
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