NA (UDI 28203)
Manufactured by Zimmer, Inc.
Device Regulatory Overview
The NA (Model/Catalog Number: 28203) is a medical device manufactured by Zimmer, Inc.. This product is indexed under FDA Product Code / Category Classification ELM within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- 28203
- Product Code / EMDN
- ELM
- Device Name
- TRIBOS 501 Kunststoffzaehne VR14-OK-A3
- Database Sync Date
- 2026-08-09 09:08:31
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 NA?
The registered manufacturer of record for NA is Zimmer, Inc..
What is the Primary UDI-DI identifier for NA?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 28203.
What classification code is assigned to this device?
This device is registered under product classification code ELM.
Similar Classification Devices (ELM)
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