STERLINK™

GUDID 08800066500214

Tyvek® Roll with CI for STERLINK™ Sterilizer is intended to be used to contain medical devices to be terminally sterilized in the STERLINK™ sterilization system. The medical devices are inserted into the roll, sealed, and then sterilized in the STERLINK™ sterilization system. After completion of the sterilization process, the roll maintains sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices for up to 1 month post sterilization.

Plasmapp Co.,Ltd.

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• Primary Device ID: 08800066500214
• NIH Device Record Key: 7466730d-881e-4fdc-9fd6-6ca078c462ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERLINK™
• Version Model Number: FR400100
• 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 Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800066500214 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212198

FDA Product Code

• JOJ: Indicator, Physical/Chemical Sterilization Process

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