gudid
Primary ID: 00
KeraStat Cream (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 Cream - Primary ID 00
Device Regulatory Overview
The KeraStat Cream (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
- Non-sterile, non-implantable wound dressing
- Database Sync Date
- 2026-08-09 09:06:27
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of KeraStat Cream?
The registered manufacturer of record for KeraStat Cream is Keranetics, Inc..
What is the Primary UDI-DI identifier for KeraStat Cream?
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.
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint