VERIFY SixCess

Basic Information

• Brand Name: VERIFY SixCess
• Primary DI: 10724995088955
• Version / Model: LCC003
• Catalog Number: LCC003
• Company Name: STERIS CORPORATION
• Labeler DUNS: 961394798
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 6
• Public Version Date: 2022-11-03
• Public Version Status: Update
• Public Device Record Key: dc9f8093-ddb8-4ceb-898f-dbf9eb689ac2
• Distribution End Date: 2022-11-02

Device Description

The VERIFY SixCess 270F 4 Challenge Packs are used to monitor steam sterilization loads and can be used to release non implant loads.

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JOJ	Indicator, physical/chemical sterilization process	General Hospital	880.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13732	Biological sterilization indicator	A sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10724995088955	GS1
Unit of Use	00724995088958	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K070895	000
K073683	000
K162758	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from direct light
• Type: Storage Environment Humidity
• Temperature Range: 30 – 60 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 32 – 86 Degrees Fahrenheit