Duns Number:961394798
Device Description: The VERIFY SixCess 275F 3 Challenge Packs are used to monitor steam sterilization loads an The VERIFY SixCess 275F 3 Challenge Packs are used to monitor steam sterilization loads and can be used to release non implant loads.
Catalog Number
LCC014
Brand Name
VERIFY SixCess
Version/Model Number
LCC014
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
61ccf3b8-56c6-4ee7-8925-5cfa1e4c6335
Public Version Date
November 03, 2020
Public Version Number
5
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 |