Plasmapp Co.,Ltd.

Address:102, cheombok-ro,Dong-gu Daegu,KR

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Indicator, Physical/Chemical Sterilization Process (JOJ) (5) Indicator, Biological Sterilization Process (FRC) (4) Sterilizer, Chemical (MLR) (2) Accessories, Implant, Dental, Endosseous (NDP) (1) Wrap, Sterilization (FRG) (1)

Premarket Exempt

No Yes

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STERLINK™ - 08800066500030 Catalog Number :

Device Description : sterilant for Low temperature plasma sterilizer STERLINK™ FPS-15s Plus.The STERL 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.

Device Class : 2

Duns Number: 695798956

Premarket Exempt : No

Product Code : MLR

Prescription Use : No

Device Count : 1

STERLINK™ - 08800066500054 Catalog Number :

Device Description : The STERLINK™ FPS-15s Plus sterilizer with STERLOAD™ cassette is a vaporized hyd 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 Class : 2

Duns Number: 695798956

Premarket Exempt : No

Product Code : MLR

Prescription Use : No

Device Count : 1

STERLINK™ - 08800066500184 Catalog Number :

Device Description : Terragene Bionova® SCBI(BT96) is a self-contained biological indicator inoculate Terragene Bionova® SCBI(BT96) is a self-contained biological indicator inoculated with viable 10^6 Geobacillus sterotheromophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydorgen peroxide sterilization processes. BT96 has Super Rapid readout at 30 minutes at 60 degree celsius.

Device Class : 2

Duns Number: 695798956

Premarket Exempt : No

Product Code : FRC, JOJ

Prescription Use : No

Device Count : 1

STERLINK™ - 08800066500191 Catalog Number :

Device Description : Terragene Chemdye® (CD42) Process Indicators (Type 1 according ISO 11140-1:2014 Terragene Chemdye® (CD42) Process Indicators (Type 1 according ISO 11140-1:2014 standard) are single-use chemical indicators that consist of a roll of self-adhesive plastic tape printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items.

Device Class : 2

Duns Number: 695798956

Premarket Exempt : No

Product Code : JOJ, FRC

Prescription Use : No

Device Count : 1

STERLINK™ - 08800066500207 Catalog Number :

Device Description : Cintape® CT40 Process Indicators (Type 1 according ISO 11140-1:2014 standard) ar Cintape® CT40 Process Indicators (Type 1 according ISO 11140-1:2014 standard) are single-use chemical indicators that consist of a roll of self-adhesive plastic tape printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items.

Device Class : 2

Duns Number: 695798956

Premarket Exempt : No

Product Code : JOJ, FRC

Prescription Use : No

Device Count : 1

STERLINK™ - 08800066500214 Catalog Number :

Device Description : Tyvek® Roll with CI for STERLINK™ Sterilizer is intended to be used to contain m 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.

Device Class : 2

Duns Number: 695798956

Premarket Exempt : No

Product Code : JOJ, FRG

Prescription Use : No

Device Count : 1

STERLINK™ - 08800066500221 Catalog Number :

Device Description : Terragene® Bionova© Reader Incubators (Mini-Bio) incubate at 60 °C and 37 °C and 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 Class : 2

Duns Number: 695798956

Premarket Exempt : No

Product Code : FRC, JOJ

Prescription Use : No

Device Count : 1

ACTILINK™ - 08800066500245 Catalog Number :

Device Description : The ACTILINK mini is indicated for removing the hydrocarbon impurities on the su The ACTILINK mini is indicated for removing the hydrocarbon impurities on the surface of the endosseosous dental implants. According to the test results, it is verified that the plasma enhanced vacuuming flow can efficiently clean the hydrocarbon impurities on the implant surface. The ACTILINK mini can process:• Dental implant fixtures made of titanium or titanium alloy

Device Class : 1

Duns Number: 695798956

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

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