gudid
Primary ID: 83045
ASSUREPlus (UDI 83045)
Manufactured by Sultan Healthcare Inc
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ASSUREPlus - Primary ID 83045
Device Regulatory Overview
The ASSUREPlus (Model/Catalog Number: 83045) is a medical device manufactured by Sultan Healthcare Inc. This product is indexed under FDA Product Code / Category Classification KCT within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 83045
- Product Code / EMDN
- KCT
- Device Name
- ASSUREPlus Self-Sealing Sterilization Pouch 5.5 x 13 (140mm x 330mm) Box of 200
- Database Sync Date
- 2026-08-09 09:03:02
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 ASSUREPlus?
The registered manufacturer of record for ASSUREPlus is Sultan Healthcare Inc.
What is the Primary UDI-DI identifier for ASSUREPlus?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 83045.
What classification code is assigned to this device?
This device is registered under product classification code KCT.
Similar Classification Devices (KCT)
Other Devices by Sultan Healthcare Inc
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