Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
Plasmapp Co., Ltd.
Plasmapp Co., Ltd.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3016075971 | 3016075971 | Plasmapp Co., Ltd. | 1 | N | 2026-01-01 | 2F, 161 Asanbaelli-ro 388beon-gil, Eumbong-myeon Asan-si Chungnam KR 31408 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 297752 | 1615048851 | K231169 | STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | MLR | 2023-05-25 |
| 297752 | 1879954758 | K223025 | Tyvek Roll with CI for STERLINK Sterilizer | FRG | 2023-05-09 |
| 297752 | 2052733844 | K223023 | Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | FRC | 2023-05-09 |
| 297752 | 1177396641 | K223015 | STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette | MLR | 2023-05-09 |
| 297752 | 1568117283 | K220345 | STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | MLR | 2023-04-14 |
| 297752 | 1431647886 | K212200 | STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette | MLR | 2021-10-22 |
| 297752 | 1212839834 | K212198 | Tyvek(R) Roll with CI for STERLINKTM Sterilizer | FRG | 2021-10-22 |
| 297752 | 1716294417 | K212193 | Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | FRC | 2021-10-22 |
Product Codes Associated With Registrations#
PMN#
GUDID#
STERILINK™ - The STERLINK plus with STERPACK plus sterilization 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.The STERLINK plus can sterilize: 1.Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors2.Medical devices with a single stainless-steel lumen with:- STERPACK plus: An inside diameter of 1.6 mm or larger and a length of 200 mm or shorter- STERLOAD: An inside diameter of 2.4 mm or larger and a length of 280 mm or shorter
2023-07-13
STERLINK™ - 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.
2021-11-26
STERLINK™ - 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.
2021-11-26
STERILINK™ - 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.
2023-07-13
STERLINK™ - 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.
2021-11-26
STERLINK™ - 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.
2021-11-26
STERILINK™ - The STERLINK mini sterilizer with STERLOAD mini 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.
2023-07-13
ACTILINK™ - The ACTILINK reborn is a device intended for use in reducing carbon contamination level on dental implant surface by means of plasma enhanced vacuuming, in a chairside.
2023-02-24
ACTILINK™ - 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
2022-03-04
STERLINK™ - 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.
2021-12-27
STERLINK™ - 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.
2021-11-26
STERLINK™ - 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.
2021-11-26