gudid
Primary ID: 1
SOURCE SURGICAL INC. (UDI 1)
Manufactured by KENPAX INTERNATIONAL LIMITED
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for SOURCE SURGICAL INC. - Primary ID 1
Device Regulatory Overview
The SOURCE SURGICAL INC. (Model/Catalog Number: 1) is a medical device manufactured by KENPAX INTERNATIONAL LIMITED. This product is indexed under FDA Product Code / Category Classification FXP within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 1
- Product Code / EMDN
- FXP
- Device Name
- Bouffant capA non-sterile head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is usually made of reinforced paper or non-woven materials. This is a single-use device.
- Database Sync Date
- 2026-08-09 09:16:45
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 SOURCE SURGICAL INC.?
The registered manufacturer of record for SOURCE SURGICAL INC. is KENPAX INTERNATIONAL LIMITED.
What is the Primary UDI-DI identifier for SOURCE SURGICAL INC.?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 1.
What classification code is assigned to this device?
This device is registered under product classification code FXP.
Similar Classification Devices (FXP)
Other Devices by KENPAX INTERNATIONAL LIMITED
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