Duns Number:040469731
Device Description: The SteriScan Extended Cycle Tube is a single-use plastic tube that is designed to hold a The SteriScan Extended Cycle Tube is a single-use plastic tube that is designed to hold a biological indicator in place during the steam sterilization process.
Catalog Number
4400
Brand Name
SteriScan
Version/Model Number
4400
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
K103321,K103321
Product Code
FRC
Product Code Name
Indicator, biological sterilization process
Public Device Record Key
d6486dee-cf7b-45e2-acb0-64b1baa1337c
Public Version Date
February 19, 2021
Public Version Number
7
DI Record Publish Date
September 13, 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 | 1528 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1557 |