Duns Number:218172765
Device Description: The VERIFY SixCess 275F 3 Minute Indicator Short are cycle verification indicators which a The VERIFY SixCess 275F 3 Minute Indicator Short are cycle verification indicators which are designed to react to all critical variables for specific sterilization cycles.
Catalog Number
PCC038
Brand Name
VERIFY
Version/Model Number
PCC038
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
JOJ
Product Code Name
Indicator, physical/chemical sterilization process
Public Device Record Key
b13d1452-e3ec-404b-8b28-0c322d03949b
Public Version Date
February 19, 2021
Public Version Number
7
DI Record Publish Date
September 06, 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. | 4 |