gudid
Primary ID: S415
Sapphire (UDI S415)
Manufactured by Omm Imports Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Sapphire - Primary ID S415
Device Regulatory Overview
The Sapphire (Model/Catalog Number: S415) is a medical device manufactured by Omm Imports Inc.. This product is indexed under FDA Product Code / Category Classification OLP within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- S415
- Product Code / EMDN
- OLP
- Device Name
- Over the counter blue LED phototherapy device for the treatment of acne.
- Database Sync Date
- 2026-08-09 09:37:52
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 Sapphire?
The registered manufacturer of record for Sapphire is Omm Imports Inc..
What is the Primary UDI-DI identifier for Sapphire?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is S415.
What classification code is assigned to this device?
This device is registered under product classification code OLP.
Similar Classification Devices (OLP)
Other Devices by Omm Imports Inc.
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