NA

Basic Information

• Brand Name: NA
• Primary DI: 00724995176730
• Version / Model: FD257
• Catalog Number: FD257
• Company Name: Corporation Steris Canada
• Labeler DUNS: 202659140
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-09
• Public Version: 4
• Public Version Date: 2022-10-21
• Public Version Status: Update
• Public Device Record Key: 4fd82daf-f1f0-426c-b6b2-3e9a1b1aa766

Device Description

The RAS 12 Long Rack is designed to enable the mechanical cleaning, rinsing, and disinfection of up to 12 robotic-assisted surgery instruments in the AMSCO 7052HP and or 7053HP Single Chamber Washer Disinfectors.

Device Characteristics

• Single Use: No
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NVE	Washer, cleaner, automated, endoscope	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62151	Sterilizer/disinfector rack	A non-sterile rack or group of shelves intended to hold medical devices in a sterilizer or chemical washer/disinfector during the sterilization or washing/disinfection cycle. It may also be used to transport medical devices to and from the process and for their temporary storage. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00724995176730	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K190081	000
K200577	000
K203199	000
K222543	000
K222849	000