Duns Number:961394798
Device Description: The VERIFY Dual Species Self-Contained Biological Indicators are for use in monitoring hea The VERIFY Dual Species Self-Contained Biological Indicators are for use in monitoring healthcare ethylene oxide (EO) sterilization processes.
Catalog Number
S3071
Brand Name
VERIFY
Version/Model Number
S3071
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 19, 2020
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
K854631,K854631
Product Code
FRC
Product Code Name
Indicator, biological sterilization process
Public Device Record Key
bb3271a0-2763-4392-a9ef-33a3a849782d
Public Version Date
October 19, 2020
Public Version Number
6
DI Record Publish Date
September 09, 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 | 1528 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1557 |