SteriScan

Basic Information

• Brand Name: SteriScan
• Primary DI: 10724995152205
• Version / Model: Six Emulator
• Catalog Number: 2200
• Company Name: STERIS CORPORATION
• Labeler DUNS: 040469731
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 250
• Record Status: Published
• Publish Date: 2016-09-13
• Public Version: 7
• Public Version Date: 2021-02-19
• Public Version Status: Update
• Public Device Record Key: 960b33c4-bb74-46bc-8ce3-2c7934c7149e
• Distribution End Date: 2020-09-11

Device Description

The SteriScan Six Steam Sterilization Emulator four-inch strip is for use in a variety of cycles and incorporates three critical variables of steam sterilization: steam, time, and temperature.

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
35362	Chemical/physical sterilization process indicator	A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50724995152203	GS1	Case	8	Not in Commercial Distribution	2020-09-11
Primary	10724995152205	GS1
Unit of Use	00724995152208	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K100891	000