NA

Basic Information

• Brand Name: NA
• Primary DI: 07350109400236
• Version / Model: 15091-12
• Catalog Number: 01509112
• Company Name: Steris Mexico, S. de R.L. de C.V.
• Labeler DUNS: 813116209
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-19
• Public Version: 3
• Public Version Date: 2020-11-24
• Public Version Status: Update
• Public Device Record Key: 80cd9325-e1bb-4d8c-80a5-01e84e81d8b9

Device Description

The Evolution ALUS Unload Table, (26 x 37.5 x 42-inch) is used with the HC-900 Evolution Steam Sterilizer.

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
FLE	Sterilizer, steam	General Hospital	880.6880	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	07350109400236	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K091136	000
K203061	000