Duns Number:695798956
Device Description: Terragene Chemdye® (CD42) Process Indicators (Type 1 according ISO 11140-1:2014 standard) 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.
Catalog Number
-
Brand Name
STERLINK™
Version/Model Number
CD42
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K212193
Product Code
FRC
Product Code Name
Indicator, Biological Sterilization Process
Public Device Record Key
f6de647c-8744-47a7-99ec-608ef1bde55b
Public Version Date
December 06, 2021
Public Version Number
1
DI Record Publish Date
November 26, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |