AMSCO

Basic Information

• Brand Name: AMSCO
• Primary DI: 00724995176648
• Version / Model: 7053HP
• Catalog Number: FH19082
• Company Name: Corporation Steris Canada
• Labeler DUNS: 202659140
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-04
• Public Version: 5
• Public Version Date: 2023-11-21
• Public Version Status: Update
• Public Device Record Key: 814a7f2e-c509-4f74-a111-64cfc6199bea

Device Description

AMSCO 7053HP Washer-Disinfector Steam Heated Unit delivers a validated and cleared process for cleaning reusable da Vinci EndoWrist X/Xi, S/Si, and Single-Site instruments and staplers.

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
MEC	Disinfector, medical devices	General Hospital	880.6992	2
NVE	Washer, cleaner, automated, endoscope	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66797	Surgical instrument washer/disinfector (chemical/thermal)	An electrically-powered unit intended to both wash and disinfect a range of surgical instruments, and typically also ancillary utensils (e.g., containers), using both heat and a disinfectant solution; it is not dedicated to washing/disinfecting a specific device type. The device includes an internal chamber containing baskets/racks onto which the devices are placed to help maximize contact with all surfaces and parts. It is used in hospitals typically in a reprocessing suite.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00724995176648	GS1

Customer Contacts

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