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Sterlink™

FDA UDI

Class II (US FDA UDI)

by Plasmapp Co., Ltd.

Identity

Trade Name
STERLINK™ FDA UDI
Generic Name
Chemical/physical sterilization process indicator FDA UDI
Device Name
Terragene Chemdye® (CD42) Process Indicators (Type 1 according ISO 11140-1:2014 standard) are single-use chemical indicators that consist of a roll of self-adhesive plastic tape printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items. FDA UDI
Model / Reference
CD42 FDA UDI
Description
Terragene Chemdye® (CD42) Process Indicators (Type 1 according ISO 11140-1:2014 standard) are single-use chemical indicators that consist of a roll of self-adhesive plastic tape printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items. FDA UDI

Identifiers

Primary DI / UDI-DI
08800066500191 FDA UDI
510(k) Number
K212193 FDA UDI
FDA Product Code
JOJ FDA UDI
FRC FDA UDI
GMDN Term
Chemical/physical sterilization process indicator FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Chemical/physical sterilization process indicator

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

Similar devices

Also classified as Chemical/physical sterilization process indicator.

Cleared under the same submission

K212193 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Plasmapp Co., Ltd.

Sources (1)

  • FDA UDI f6de647c-8744-47a7-99ec-608ef1bde55b 35 fields · synced May 30, 2026