Duns Number:040469731
Device Description: The VERIFY SixCess MF4 STEAM Emulating Indicator is a cycle-specific indicator monitoring The VERIFY SixCess MF4 STEAM Emulating Indicator is a cycle-specific indicator monitoring all critical parameters of a steam sterilization cycle.
Catalog Number
PCC072
Brand Name
VERIFY SIXCESS
Version/Model Number
PCC072
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
ff9d8746-5141-4ec0-9eb2-6658018ddf6d
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
April 19, 2019
Package DI Number
50724995154733
Quantity per Package
8
Contains DI Package
10724995154735
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |