Sterrad

Basic Information

• Brand Name: Sterrad
• Primary DI: 10705037016198
• Version / Model: 14100
• Catalog Number: 14100
• Company Name: ADVANCED STERILIZATION PRODUCTS SERVICES INC.
• Labeler DUNS: 947451626
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 250
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2023-06-22
• Public Version Status: Update
• Public Device Record Key: 2c5d32b4-1202-48ab-b469-9856b04f1c08

Device Description

Chemical Indicator Strip

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: Yes
• 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	20705037016195	GS1	Case	4	In Commercial Distribution
Primary	10705037016198	GS1
Unit of Use	80705037016197	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K103218	000
K111518	000
K921910	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Wrap processed indicator in a plastic bag. Do not cover processed Indicator with transparent tape.
• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dry area away from sources of light, and acids, bases and STERRAD sterilizer both before and after sterilization. Avoid direct contact with paper or cardboard.
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius