Duns Number:194877072
Device Description: For monitoring Steam & Chemical Vapor sterilization processes
Catalog Number
SK-056
Brand Name
SPORVIEW CULTURE SET STARTER KIT
Version/Model Number
SK-056
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
Product Code
FRC
Product Code Name
Indicator, biological sterilization process
Public Device Record Key
a754855c-bd72-4d83-b443-d050a68dc695
Public Version Date
February 08, 2021
Public Version Number
3
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 |