SURGISTAIN PLUS (4 Liter RB53)

FDA UDI

Class I (US FDA UDI)

by Ruhof Corporation

Identity

Trade Name: SURGISTAIN PLUS (4 Liter RB53) FDA UDI
Generic Name: Instrument anti-oxidation agent FDA UDI
Device Name: Enzymatic detergents used to clean medical instruments. FDA UDI
Model / Reference: 34573-31 FDA UDI
Description: Enzymatic detergents used to clean medical instruments. FDA UDI

Identifiers

Primary DI / UDI-DI: 00810929042049 FDA UDI
FDA Product Code: FLG FDA UDI
GMDN Term: Instrument anti-oxidation 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

Yes

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: Instrument anti-oxidation agent

SURGISTAIN PLUS (4 Liter RB53) by Ruhof Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Instrument anti-oxidation agent.

SURGISTAIN (55 Gallon/220 Liter Drum) — Ruhof Corporation · Class I
SURGISTAIN (2 Liter RB38) — Ruhof Corporation · Class I
SURGISTAIN (4 Liter FB63) — Ruhof Corporation · Class I
SURGISTAIN (1 Liter bottle) — Ruhof Corporation · Class I
SURGISTAIN (4.2oz/125ml bottle) — Ruhof Corporation · Class I
SURGISTAIN (5 Liter FB38) — Ruhof Corporation · Class I
SURGISTAIN (15 Gallon Drum) — Ruhof Corporation · Class I
SURGISTAIN (4Liter RB53) — Ruhof Corporation · Class I

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: Ruhof Corporation

Sources (1)

FDA UDI fa7a3eda-92a8-4751-ba0d-9eb455a8778a 34 fields · synced May 30, 2026