gudid
Primary ID: 00
KeraStat Gel (UDI 00)
Manufactured by Keranetics, Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for KeraStat Gel - Primary ID 00
Device Regulatory Overview
The KeraStat Gel (Model/Catalog Number: 00) is a medical device manufactured by Keranetics, Inc.. This product is indexed under FDA Product Code / Category Classification KGN within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 00
- Product Code / EMDN
- KGN
- Device Name
- Sterile, non-implantable, water-based gelatinous (hydrogel) wound dressing
- Database Sync Date
- 2026-08-09 09:06:27
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 KeraStat Gel?
The registered manufacturer of record for KeraStat Gel is Keranetics, Inc..
What is the Primary UDI-DI identifier for KeraStat Gel?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00.
What classification code is assigned to this device?
This device is registered under product classification code KGN.
Similar Classification Devices (KGN)
Other Devices by Keranetics, Inc.
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