Duns Number:102530326
Device Description: Self-contained biological indicator for use in steam sterilization processes. Log 5 popul Self-contained biological indicator for use in steam sterilization processes. Log 5 population. 25 count box.
Catalog Number
SEZS/525
Brand Name
Smart-Read EZTest Steam
Version/Model Number
Log 5
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
27f6d086-6c2b-4909-af06-b17f20ba35c0
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 31, 2017
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. | 29 |