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 Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer 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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