Duns Number:204137145
Device Description: Self-contained biological indicators for steam sterilization containing bacterial endospor Self-contained biological indicators for steam sterilization containing bacterial endospores of G. stearothermophilus. 100-count.
Catalog Number
SCI-BI100
Brand Name
ENSURE Biological Indicators
Version/Model Number
SCI-BI100
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)
-
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
17a55b9d-07f2-4e3d-8ab3-09df3c48505d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 02, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 114 |