STERILINK™
GUDID 08800066500313
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.
Plasmapp Co.,Ltd.
Plasma sterilizer| Primary Device ID | 08800066500313 |
| NIH Device Record Key | dcdb15df-74a7-4b4f-a7ca-d330de0e6e9d |
| Commercial Distribution Discontinuation | 2023-07-13 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | STERILINK™ |
| Version Model Number | 110V |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800066500313 [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 | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-10-25 |
| Device Publish Date | 2023-07-13 |
Devices Manufactured by Plasmapp Co.,Ltd.
| 08800066500313 - STERILINK™ | 2023-10-25The 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. |
| 08800066500313 - STERILINK™ | 2023-10-25 The STERLINK™ FPS-15s Plus sterilizer with STERLOAD™ cassette is a vaporized hydrogen peroxide sterilizer intended for use i |
| 08800066500269 - ACTILINK™ | 2023-03-06 The ACTILINK reborn is a device intended for use in reducing carbon contamination level on dental implant surface by means of pl |
| 08800066500245 - ACTILINK™ | 2022-03-14 The ACTILINK mini is indicated for removing the hydrocarbon impurities on the surface of the endosseosous dental implants. Accor |
| 08800066500221 - STERLINK™ | 2022-01-04 Terragene® Bionova© Reader Incubators (Mini-Bio) incubate at 60 °C and 37 °C and read the Terragene® Bionova© SCBI for flu |
| 08800066500030 - STERLINK™ | 2021-12-06 sterilant for Low temperature plasma sterilizer STERLINK™ FPS-15s Plus. The STERLOAD is group of sterilant cassette products w |
| 08800066500054 - STERLINK™ | 2021-12-06 The STERLINK™ FPS-15s Plus sterilizer with STERLOAD™ cassette is a vaporized hydrogen peroxide sterilizer intended for use i |
| 08800066500184 - STERLINK™ | 2021-12-06 Terragene Bionova® SCBI(BT96) is a self-contained biological indicator inoculated with viable 10^6 Geobacillus sterotheromophil |
| 08800066500191 - STERLINK™ | 2021-12-06 Terragene Chemdye® (CD42) Process Indicators (Type 1 according ISO 11140-1:2014 standard) are single-use chemical indicators th |
Trademark Results [STERILINK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STERILINK 78570648 3172320 Live/Registered |
STERIS CORPORATION 2005-02-18 |
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