STERLINK™

Primary DI
08800066500030
Brand
STERLINK™
Company
Plasmapp Co.,Ltd.
Model
STERLOAD
Device description
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.
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
Single use
true

Product Codes#

Code, Name table
CodeName
MLRSterilizer, Chemical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLRSterilizer, ChemicalGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212200000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212200000STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM CassettePlasmapp Co,., Ltd.2021-10-22MLR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800066500030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800066500030088000665000308800066500030

GMDN Terms#

Term, Definition table
TermDefinition
Hydrogen peroxide device sterilantA gaseous or liquid substance that includes hydrogen peroxide (H2O2) as its primary agent to completely destroy or eliminate all harmful microorganisms on a medical device (e.g., surgical or dental instrument). The medical device is typically bathed by the substance for a specified period of time in order to achieve sterilization. The substance may be presented in discrete quantities to accommodate the requirements of a sterilization device or system. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
695798956
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800066500306STERILINK™110V2023-07-13
08800066500191STERLINK™CD422021-11-26
08800066500207STERLINK™CT402021-11-26
08800066500313STERILINK™110V2023-07-13
08800066500054STERLINK™FPS-15s Plus2021-11-26
08800066500320STERILINK™110V2023-07-13
08800066500269ACTILINK™ACTILINK reborn2023-02-24
08800066500245ACTILINK™ACTILINK mini2022-03-04
08800066500221STERLINK™Mini-bio2021-12-27
08800066500184STERLINK™BT962021-11-26
08800066500214STERLINK™FR4001002021-11-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800066500306STERILINK™Plasmapp Co.,Ltd.MLR2023-07-13
08800066500320STERILINK™Plasmapp Co.,Ltd.MLR2023-07-13
00889024636118Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636132Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636170Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636187Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636224Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636231Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636255Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636279Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636286Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636309Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636323Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636330Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636378Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636385Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636408Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636415Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636439Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636453Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636460Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636477Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636507Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636545Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636583Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636613Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636675Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636682Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636699Trilogy®Zimmer, Inc.MLR2022-02-25
00850012210023Sterilucent™ Sterilant DiscSTERILUCENT, INC.MLR2020-04-29