Waters IGL Cold Storage Solution (UDI CSS/2000)
Manufactured by INSTITUT GEORGES LOPEZ
Device Regulatory Overview
The Waters IGL Cold Storage Solution (Model/Catalog Number: CSS/2000) is a medical device manufactured by INSTITUT GEORGES LOPEZ. This product is indexed under FDA Product Code / Category Classification KDN within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: I...
Technical Specifications
- Model Number
- CSS/2000
- Product Code / EMDN
- KDN
- Device Name
- Clear, sterile, non-pyrogenic solution intended for hypothermic flushing and storage of kidney, liver and pancreas.
- Database Sync Date
- 2026-08-09 09:48:33
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 Waters IGL Cold Storage Solution?
The registered manufacturer of record for Waters IGL Cold Storage Solution is INSTITUT GEORGES LOPEZ.
What is the Primary UDI-DI identifier for Waters IGL Cold Storage Solution?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is CSS/2000.
What classification code is assigned to this device?
This device is registered under product classification code KDN.
Similar Classification Devices (KDN)
Other Devices by INSTITUT GEORGES LOPEZ
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