VERIFY SixCess

Basic Information

• Brand Name: VERIFY SixCess
• Primary DI: 00724995218577
• Version / Model: LCC014
• Catalog Number: LCC014
• Company Name: STERIS CORPORATION
• Labeler DUNS: 961394798
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-07
• Public Version: 1
• Public Version Date: 2022-11-15
• Public Version Status: New
• Public Device Record Key: fd5ca3ef-6273-41a0-ae33-2621b445577f

Device Description

The VERIFY SixCess 275F 3 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
Package	10724995218574	GS1	Box	20	In Commercial Distribution
Primary	00724995218577	GS1
Previous	10724995088979	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 Temperature
• Temperature Range: 32 – 86 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 30 – 60 Percent (%) Relative Humidity