Duns Number:601985976
Device Description: Spore Test Monitoring Service Dry Heat or Steam, Mail-in 12/box
Catalog Number
-
Brand Name
STERIDENT
Version/Model Number
400633
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)
Yes
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
K023716
Product Code
FRC
Product Code Name
Indicator, Biological Sterilization Process
Public Device Record Key
e0aa7ad9-df55-454e-b60a-b5df7a9e99f7
Public Version Date
April 13, 2020
Public Version Number
2
DI Record Publish Date
September 20, 2018
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 28 |