Sterlink™

FDA UDI

Class II (US FDA UDI)

by Plasmapp Co., Ltd.

Identity

Trade Name: STERLINK™ FDA UDI
Generic Name: Sterilization packaging, single-use FDA UDI
Device Name: 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. FDA UDI
Model / Reference: FR400100 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI: 08800066500214 FDA UDI
510(k) Number: K212198 FDA UDI
FDA Product Code: JOJ FDA UDI
FRG FDA UDI
GMDN Term: Sterilization packaging, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.2800 FDA UDI
880.6850 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Sterilization packaging, single-use

Sterlink™ by Plasmapp Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class II
Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Plasmapp Co., Ltd.

Sources (1)

FDA UDI 7466730d-881e-4fdc-9fd6-6ca078c462ea 35 fields · synced Jun 7, 2026