Flex Surgical Instrument Washer

Basic Information

• Brand Name: Flex Surgical Instrument Washer
• Primary DI: 10841736111663
• Version / Model: CS-0040-000
• Catalog Number: CS-0040-000
• Company Name: SKYTRON LLC
• Labeler DUNS: 078375583
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-01
• Public Version: 2
• Public Version Date: 2023-10-03
• Public Version Status: Update
• Public Device Record Key: 5fa07228-58b7-404a-a5e1-853d5072bfb1

Device Description

Flex Surgical Instrument Washer

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• 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
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	10841736111663	GS1

Customer Contacts

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