Home GUDID 08800066500054 STERLINK™
Primary DI 08800066500054
Brand STERLINK™
Company Plasmapp Co.,Ltd.
Model FPS-15s Plus
Device description 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.
Published 2021-11-26
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true
Product Codes# Code, Name table Code Name MLR Sterilizer, Chemical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MLR Sterilizer, Chemical General Hospital 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08800066500054 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800066500054 08800066500054 8800066500054
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity 30 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Storage Environment Temperature 10 Degrees Celsius 40 Degrees Celsius
Regulatory Flags# DUNS number 695798956 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08800066500306 STERILINK™ Plasmapp Co.,Ltd. MLR 2023-07-13 08800066500320 STERILINK™ Plasmapp Co.,Ltd. MLR 2023-07-13 00889024636118 Trilogy® Zimmer, Inc. MLR 2022-02-25 00889024636132 Trilogy® Zimmer, Inc. MLR 2022-02-25 00889024636170 Trilogy® Zimmer, Inc. MLR 2022-02-25 00889024636187 Trilogy® Zimmer, Inc. MLR 2022-02-25 00889024636224 Trilogy® Zimmer, Inc. MLR 2022-02-25 00889024636231 Trilogy® Zimmer, Inc. MLR 2022-02-25 00889024636255 Trilogy® Zimmer, Inc. MLR 2022-02-25 00889024636279 Trilogy® Zimmer, Inc. MLR 2022-02-25 00889024636286 Trilogy® Zimmer, Inc. MLR 2022-02-25 00889024636309 Trilogy® Zimmer, Inc. MLR 2022-02-25 00889024636323 Trilogy® Zimmer, Inc. MLR 2022-02-25 00889024636330 Trilogy® Zimmer, Inc. MLR 2022-02-25 00889024636378 Trilogy® Zimmer, Inc. MLR 2022-02-25 00889024636385 Trilogy® Zimmer, Inc. MLR 2022-02-25 00889024636408 Trilogy® Zimmer, Inc. MLR 2022-02-25 00889024636415 Trilogy® Zimmer, Inc. MLR 2022-02-25 00889024636439 Trilogy® Zimmer, Inc. MLR 2022-02-25 00889024636453 Trilogy® Zimmer, Inc. MLR 2022-02-25 00889024636460 Trilogy® Zimmer, Inc. MLR 2022-02-25 00889024636477 Trilogy® Zimmer, Inc. MLR 2022-02-25 00889024636507 Trilogy® Zimmer, Inc. MLR 2022-02-25 00889024636545 Trilogy® Zimmer, Inc. MLR 2022-02-25 00889024636583 Trilogy® Zimmer, Inc. MLR 2022-02-25 00889024636613 Trilogy® Zimmer, Inc. MLR 2022-02-25 00889024636675 Trilogy® Zimmer, Inc. MLR 2022-02-25 00889024636682 Trilogy® Zimmer, Inc. MLR 2022-02-25 00850012210023 Sterilucent™ Sterilant Disc STERILUCENT, INC. MLR 2020-04-29 00889024569485 Trilogy® Zimmer, Inc. MLR 2019-04-10