Duns Number:194877072
Device Description: In-office biological indicators for use in monitoring the efficacy of steam sterilization In-office biological indicators for use in monitoring the efficacy of steam sterilization processes.
Catalog Number
SCP-025
Brand Name
SPORVIEW SELF-CONTAINED STEAM BI
Version/Model Number
SCP-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
20a5e16e-6102-4acb-8a72-3da275ca044b
Public Version Date
March 29, 2018
Public Version Number
2
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 |