SURGISTAIN (60 Liter Drum)

Basic Information

• Brand Name: SURGISTAIN (60 Liter Drum)
• Primary DI: 00810929012301
• Version / Model: 34572-38
• Company Name: Ruhof Corporation
• Labeler DUNS: 082779828
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-30
• Public Version: 1
• Public Version Date: 2025-07-08
• Public Version Status: New
• Public Device Record Key: 23427b8a-fc24-4cec-9b9c-56a529100be0

Device Description

Enzymatic detergents used to clean medical instruments.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	880.6150	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58062	Instrument anti-oxidation agent	A liquid substance intended to prevent corrosion on the surface of stainless steel medical/surgical instruments (e.g., specula, forceps) through its anti-oxidation properties. It is typically a concentrated phosphoric acid (H3PO4) that is used as specified by the manufacturer in an aqueous solution to treat devices by manual soaking or in an ultrasonic water bath. Also known as an instrument renovating agent, it is intended to remove protein stains, iron oxide deposits, and other oxide stains to prevent rust pitting and help improve instrument longevity. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810929012301	GS1