AccessGUDID - DEVICE: STERLINK™ (08800066500191)

GUDID

Device Identifier (DI) Information

Brand Name: STERLINK™
Version or Model: CD42
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Plasmapp Co.,Ltd.

Primary DI Number: 08800066500191
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 695798956 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35362	Chemical/physical sterilization process indicator	A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change (non-electrical) to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOJ	Indicator, Physical/Chemical Sterilization Process
FRC	Indicator, Biological Sterilization Process

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212193	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 30 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f6de647c-8744-47a7-99ec-608ef1bde55b
Public Version Date: February 21, 2025
Public Version Number: 2
DI Record Publish Date: November 26, 2021