STERLINK™

Basic Information

• Brand Name: STERLINK™
• Primary DI: 08800066500221
• Version / Model: Mini-bio
• Company Name: Plasmapp Co.,Ltd.
• Labeler DUNS: 695798956
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-27
• Public Version: 1
• Public Version Date: 2022-01-04
• Public Version Status: New
• Public Device Record Key: 53be54c6-5a80-49ef-9b8c-7b5807e4a4f5

Device Description

Terragene® Bionova© Reader Incubators (Mini-Bio) incubate at 60 °C and 37 °C and read the Terragene® Bionova© SCBI for fluorescent results at the times prescribed in the User Manuals.

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRC	Indicator, Biological Sterilization Process	General Hospital	880.2800	2
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	880.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62357	Biological sterilization indicator reader	A mains electricity (AC-powered) device designed to accept a biological sterilization indicator (bacterial spores) and to rapidly indicate whether adequate sterilization conditions have been achieved by testing the resistance of the biological indicator previously exposed to a sterilization process (e.g., by steam, or chemical sterilization). It is a bench-top unit intended to provide suitable incubation conditions for the biological indicator and to detect fluorescent enzymatic signals that correlate with the resistance of the biological indicator.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800066500221	GS1

Premarket Submissions

Submission Number	Supplement Number
K212193	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 30 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius