gudid
Primary ID: KCP-35-2
Ultem Koh Cup (UDI KCP-35-2)
Manufactured by Coopersurgical, Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Ultem Koh Cup - Primary ID KCP-35-2
Device Regulatory Overview
The Ultem Koh Cup (Model/Catalog Number: KCP-35-2) is a medical device manufactured by Coopersurgical, Inc.. This product is indexed under FDA Product Code / Category Classification HEW within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- KCP-35-2
- Product Code / EMDN
- HEW
- Device Name
- Ultem Koh Cup Non- Conductive - Vaginal Fornices Delineator 3.5 cm
- Database Sync Date
- 2026-08-09 10:01:36
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 Ultem Koh Cup?
The registered manufacturer of record for Ultem Koh Cup is Coopersurgical, Inc..
What is the Primary UDI-DI identifier for Ultem Koh Cup?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is KCP-35-2.
What classification code is assigned to this device?
This device is registered under product classification code HEW.
Similar Classification Devices (HEW)
Other Devices by Coopersurgical, Inc.
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