STERILINK™

Basic Information

• Brand Name: STERILINK™
• Primary DI: 08800066500313
• Version / Model: 110V
• Company Name: Plasmapp Co.,Ltd.
• Labeler DUNS: 695798956
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-13
• Public Version: 2
• Public Version Date: 2023-10-25
• Public Version Status: Update
• Public Device Record Key: dcdb15df-74a7-4b4f-a7ca-d330de0e6e9d
• Distribution End Date: 2023-07-13

Device Description

The STERLINK™ FPS-15s Plus sterilizer with STERLOAD™ cassette is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal and nonmetal medical devices used in healthcare facilities. A pre-programmed sterilization lumen cycle operates at low pressure and low temperature and is thus suitable for processing medical devices sensitive to heat and moisture.

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
MLR	Sterilizer, Chemical	General Hospital	880.6860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36305	Plasma sterilizer	A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using vapours (or gases) in plasma state; it is typically used for products sensitive to high temperature and humidity. It typically includes a treatment chamber with shelves where the devices to be sterilized are placed, usually after cleaning of gross debris and then packed; a means to introduce the vapour [e.g., hydrogen peroxide (H2O2)] into the chamber; electrodes that are activated to convert the vapour into plasma; a radio-frequency generator; and cycle controls. The device is available in stand-alone (bulk) and tabletop units.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800066500313	GS1

Premarket Submissions

Submission Number	Supplement Number
K212200	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 45 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: – 90 Percent (%) Relative Humidity