gudid
Primary ID: OUSKTS
bioKOTE (UDI OUSKTS)
Manufactured by COLLAGEN MATRIX, INC.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for bioKOTE - Primary ID OUSKTS
Device Regulatory Overview
The bioKOTE (Model/Catalog Number: OUSKTS) is a medical device manufactured by COLLAGEN MATRIX, INC.. This product is indexed under FDA Product Code / Category Classification LYC within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- OUSKTS
- Product Code / EMDN
- LYC
- Device Name
- Collagen Dental Dressing
- Database Sync Date
- 2026-08-09 09:43:33
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 bioKOTE?
The registered manufacturer of record for bioKOTE is COLLAGEN MATRIX, INC..
What is the Primary UDI-DI identifier for bioKOTE?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is OUSKTS.
What classification code is assigned to this device?
This device is registered under product classification code LYC.
Similar Classification Devices (LYC)
Other Devices by COLLAGEN MATRIX, INC.
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