STERLINK™

GUDID 08800066500030

sterilant for Low temperature plasma sterilizer STERLINK™ FPS-15s Plus. The STERLOAD is group of sterilant cassette products which are designed to be used only by STERLINK™ sterilizer products, low temperature plasma sterilization system. The STERLOAD is supposed to be inserted in the STERLINK™ chamber to proceed sterilization process.

Plasmapp Co.,Ltd.

Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant Hydrogen peroxide device sterilant

• Primary Device ID: 08800066500030
• NIH Device Record Key: b17b6c2b-43a4-4a31-a274-a1cc65d94a51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERLINK™
• Version Model Number: STERLOAD
• Company DUNS: 695798956
• Company Name: Plasmapp Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800066500030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212200

FDA Product Code

• MLR: Sterilizer, Chemical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-06
• Device Publish Date: 2021-11-26

On-Brand Devices [STERLINK™]

• 08800066500214: Tyvek® Roll with CI for STERLINK™ Sterilizer is intended to be used to contain medical device
• 08800066500207: Cintape® CT40 Process Indicators (Type 1 according ISO 11140-1:2014 standard) are single-use ch
• 08800066500191: Terragene Chemdye® (CD42) Process Indicators (Type 1 according ISO 11140-1:2014 standard) are s
• 08800066500184: Terragene Bionova® SCBI(BT96) is a self-contained biological indicator inoculated with viable 1
• 08800066500054: The STERLINK™ FPS-15s Plus sterilizer with STERLOAD™ cassette is a vaporized hydrogen peroxi
• 08800066500030: sterilant for Low temperature plasma sterilizer STERLINK™ FPS-15s Plus. The STERLOAD is group
• 08800066500221: Terragene® Bionova© Reader Incubators (Mini-Bio) incubate at 60 °C and 37 °C and read the Te