GN Otometrics A/S (UDI 1085 Vision Denied Solution Kit (50 sets))
Manufactured by Natus Medical Denmark ApS
Device Regulatory Overview
The GN Otometrics A/S (Model/Catalog Number: 1085 Vision Denied Solution Kit (50 sets)) is a medical device manufactured by Natus Medical Denmark ApS. This product is indexed under FDA Product Code / Category Classification GWN within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 1085 Vision Denied Solution Kit (50 sets)
- Product Code / EMDN
- GWN
- Device Name
- 1085 Vision Denied Solution Kit (50 sets)
- Database Sync Date
- 2026-08-09 09:12:40
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 GN Otometrics A/S?
The registered manufacturer of record for GN Otometrics A/S is Natus Medical Denmark ApS.
What is the Primary UDI-DI identifier for GN Otometrics A/S?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 1085 Vision Denied Solution Kit (50 sets).
What classification code is assigned to this device?
This device is registered under product classification code GWN.
Similar Classification Devices (GWN)
Other Devices by Natus Medical Denmark ApS
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