Oto Ease 12pk Display Box (UDI NA)
Manufactured by Westone Laboratories, Inc.
Device Regulatory Overview
The Oto Ease 12pk Display Box (Model/Catalog Number: NA) is a medical device manufactured by Westone Laboratories, Inc.. This product is indexed under FDA Product Code / Category Classification KMJ within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz consumer sized semi transparent flexible plastic bott...
Technical Specifications
- Model Number
- NA
- Product Code / EMDN
- KMJ
- Device Name
- Earmold Lubricant
- Database Sync Date
- 2026-08-09 09:37:40
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 Oto Ease 12pk Display Box?
The registered manufacturer of record for Oto Ease 12pk Display Box is Westone Laboratories, Inc..
What is the Primary UDI-DI identifier for Oto Ease 12pk Display Box?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is NA.
What classification code is assigned to this device?
This device is registered under product classification code KMJ.
Similar Classification Devices (KMJ)
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