FDA.reportPublic FDA data

STERLINK™

Primary DI
08800066500214
Brand
STERLINK™
Company
Plasmapp Co.,Ltd.
Model
FR400100
Device description
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.
Published
2021-11-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRGWrap, Sterilization
JOJIndicator, Physical/Chemical Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212198000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212198000Tyvek(R) Roll with CI for STERLINKTM SterilizerPlasmapp Co,., Ltd.2021-10-22FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800066500214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800066500214088000665002148800066500214

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 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
08800066500030STERLINK™STERLOAD2021-11-26
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995362973VERIFYALBERT BROWNE LIMITEDJOJ2026-07-16
20680651497639HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497646HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497653HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497660HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497677HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497684HalyardO&M HALYARD, INC.FRG2026-07-16
30818087011618Propper Vapor Line IntegratorsPROPPER MANUFACTURING COMPANY, INC.JOJ2026-07-16
00859464007731Turbett Surgical, Inc.Turbett Surgical IncFRG2026-07-14
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08404535030761Brasseler USAPeter Brasseler Holdings, LLCFRG2026-07-13
08404535030792Brasseler USAPeter Brasseler Holdings, LLCFRG2026-07-13
00840456206881JMUJMU DENTAL, INCFRG2026-07-08
00840456206881JMUJMU DENTAL, INCJOJ2026-07-08
00840456206898JMUJMU DENTAL, INCFRG2026-07-08
00840456206898JMUJMU DENTAL, INCJOJ2026-07-08
00840456206928JMUJMU DENTAL, INCFRG2026-07-08
00840456206928JMUJMU DENTAL, INCJOJ2026-07-08
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00850088572056Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCFRG2026-06-22
00850088572063Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCFRG2026-06-22