Prolystica

FDA UDI

Class I (US FDA UDI)

by Steris Corporation

Identity

Trade Name: Prolystica FDA UDI
Generic Name: Medical device cleaning agent FDA UDI
Device Name: Prolystica 2X Concentrate Neutral 2.5-Gallon is designed for use in both manual and automated cleaning of appropriate medical devices including surgical instruments. FDA UDI
Model / Reference: 1C3210 FDA UDI
Description: Prolystica 2X Concentrate Neutral 2.5-Gallon is designed for use in both manual and automated cleaning of appropriate medical devices including surgical instruments. FDA UDI

Identifiers

Catalog Number: 1C3210 FDA UDI
Primary DI / UDI-DI: 00724995090982 FDA UDI
FDA Product Code: FLG FDA UDI
GMDN Term: Medical device cleaning agent FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6150 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Medical device cleaning agent

Prolystica by Steris Corporation — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Steris Corporation

Sources (1)

FDA UDI dad9941c-4fc6-431c-8dc4-d702f031b904 35 fields · synced Jun 8, 2026