Duns Number:040469731
Device Description: The VERIFY All-In-One STEAM Reusable Test Pack with Step Counter includes 1 test pack with The VERIFY All-In-One STEAM Reusable Test Pack with Step Counter includes 1 test pack with Step Counter and 200 VERIFY STEAM Integrating Indicators.
Catalog Number
LCB036
Brand Name
VERIFY
Version/Model Number
LCB036
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
-
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
c95da439-9376-4b3d-a513-92e38329f475
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
December 19, 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 |