Duns Number:194877072
Device Description: Single use test pack designed to routinely challenge the steam sterilization process in bo Single use test pack designed to routinely challenge the steam sterilization process in both gravity and prevacuum steam sterilizers
Catalog Number
SBT-025
Brand Name
SPORVIEW STEAM BI TEST PACK-25 CNTRLS
Version/Model Number
SBT-025
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
-
Product Code
FRC
Product Code Name
Indicator, biological sterilization process
Public Device Record Key
5777abfb-4b54-438f-be2f-fbca5a9cd533
Public Version Date
October 11, 2021
Public Version Number
4
DI Record Publish Date
November 15, 2016
Package DI Number
50732224720987
Quantity per Package
25
Contains DI Package
10732224720989
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 26 |