gudid
Primary ID: 1
B Cassette (UDI 1)
Manufactured by OPTI MEDICAL SYSTEMS, INC.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for B Cassette - Primary ID 1
Device Regulatory Overview
The B Cassette (Model/Catalog Number: 1) is a medical device manufactured by OPTI MEDICAL SYSTEMS, INC.. This product is indexed under FDA Product Code / Category Classification GKR within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 1
- Product Code / EMDN
- GKR
- Device Name
- B Cassette Carton
- Database Sync Date
- 2026-08-09 09:46:58
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 B Cassette?
The registered manufacturer of record for B Cassette is OPTI MEDICAL SYSTEMS, INC..
What is the Primary UDI-DI identifier for B Cassette?
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 GKR.
Similar Classification Devices (GKR)
Other Devices by OPTI MEDICAL SYSTEMS, INC.
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