Duns Number:204137145
Device Description: Chemical indicator strips designed for use in steam sterilizers operating at 132°C to 135° Chemical indicator strips designed for use in steam sterilizers operating at 132°C to 135°C (270°F to 276°F) to give a visible indication that sterilization conditions have been met.
Catalog Number
SCI134-US
Brand Name
Sterilization Monitors, Steam
Version/Model Number
SCI134-US
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRT
Product Code Name
Indicator, Sterilization
Public Device Record Key
8f849c65-0aa6-4957-9776-1148c0f1bf9f
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
August 02, 2016
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 114 |