Duns Number:194877072
Device Description: Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.
Catalog Number
SVK-012
Brand Name
STEAM TRAY VERIFICATION KIT
Version/Model Number
SVK-012
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)
Yes
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
K905425,K905425
Product Code
FRC
Product Code Name
Indicator, biological sterilization process
Public Device Record Key
5a8ceebe-e300-4ca4-a629-15d5c4fe1f78
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
November 15, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 26 |