N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00724995176785
• Version / Model: FD80200
• Catalog Number: FD80200
• Company Name: Corporation Steris Canada
• Labeler DUNS: 202659140
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-06
• Public Version: 2
• Public Version Date: 2021-01-28
• Public Version Status: Update
• Public Device Record Key: 94e809ee-9e67-4c2f-9abb-dc57fb279825

Device Description

The Upper universal insert used with 7052HP and 7053HP 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: Yes
• 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
MEC	Disinfector, medical devices	General Hospital	880.6992	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	00724995176785	GS1

Customer Contacts

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