Duns Number:040469731
Device Description: The SteriScan Six Steam Sterilization Emulator four-inch strip is for use in a variety of The SteriScan Six Steam Sterilization Emulator four-inch strip is for use in a variety of cycles and incorporates three critical variables of steam sterilization: steam, time, and temperature.
Catalog Number
2200
Brand Name
SteriScan
Version/Model Number
Six Emulator
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 11, 2020
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
K100891,K100891,K100891
Product Code
JOJ
Product Code Name
Indicator, physical/chemical sterilization process
Public Device Record Key
960b33c4-bb74-46bc-8ce3-2c7934c7149e
Public Version Date
February 19, 2021
Public Version Number
7
DI Record Publish Date
September 13, 2016
Package DI Number
50724995152203
Quantity per Package
8
Contains DI Package
10724995152205
Package Discontinue Date
September 11, 2020
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1528 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1557 |