Waters IGL Cold Storage Solution

FDA UDI

Class II (US FDA UDI)

by Institut Georges Lopez

Identity

Trade Name: Waters IGL Cold Storage Solution FDA UDI
Generic Name: Donor-organ/tissue/cell preservation solution FDA UDI
Device Name: Clear, sterile, non-pyrogenic solution intended for hypothermic flushing and storage of kidney, liver and pancreas. FDA UDI
Model / Reference: CSS/1000 FDA UDI
Description: Clear, sterile, non-pyrogenic solution intended for hypothermic flushing and storage of kidney, liver and pancreas. FDA UDI

Identifiers

Primary DI / UDI-DI: 13700911900591 FDA UDI
FDA Product Code: KDN FDA UDI
KDL FDA UDI
GMDN Term: Donor-organ/tissue/cell preservation solution FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5880 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Donor-organ/tissue/cell preservation solution

Waters IGL Cold Storage Solution by Institut Georges Lopez — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Institut Georges Lopez

Sources (1)

FDA UDI 5b593c53-a4c3-441d-9148-897f13d331b7 34 fields · synced Jun 8, 2026