gudid
Primary ID: GSL-S
Guardian Splint (UDI GSL-S)
Manufactured by BM KOREA CO., LTD
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Guardian Splint - Primary ID GSL-S
Device Regulatory Overview
The Guardian Splint (Model/Catalog Number: GSL-S) is a medical device manufactured by BM KOREA CO., LTD. This product is indexed under FDA Product Code / Category Classification NOC within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- GSL-S
- Product Code / EMDN
- NOC
- Device Name
- This product is made by molding thermoplastic synthetic resin to the affected area, and is used to support and immobilize the joint and surrounding areas.
- Database Sync Date
- 2026-08-09 09:21:16
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 Guardian Splint?
The registered manufacturer of record for Guardian Splint is BM KOREA CO., LTD.
What is the Primary UDI-DI identifier for Guardian Splint?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is GSL-S.
What classification code is assigned to this device?
This device is registered under product classification code NOC.
Similar Classification Devices (NOC)
Other Devices by BM KOREA CO., LTD
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