gudid
Primary ID: PrefGel
Straumann PrefGel (UDI PrefGel)
Manufactured by Institut Straumann AG
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Straumann PrefGel - Primary ID PrefGel
Device Regulatory Overview
The Straumann PrefGel (Model/Catalog Number: PrefGel) is a medical device manufactured by Institut Straumann AG. This product is indexed under FDA Product Code / Category Classification KJJ within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- PrefGel
- Product Code / EMDN
- KJJ
- Device Name
- Straumann PrefGel, 5 x 0.6 ml (24% EDTA)
- Database Sync Date
- 2026-08-09 09:19:46
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 Straumann PrefGel?
The registered manufacturer of record for Straumann PrefGel is Institut Straumann AG.
What is the Primary UDI-DI identifier for Straumann PrefGel?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is PrefGel.
What classification code is assigned to this device?
This device is registered under product classification code KJJ.
Similar Classification Devices (KJJ)
Other Devices by Institut Straumann AG
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