Duns Number:040469731
Device Description: The VERIFY All-In-One Steam Reusable Test Pack with Step Counter is designed to challenge The VERIFY All-In-One Steam Reusable Test Pack with Step Counter is designed to challenge vacuum assisted steam sterilizers operating at 270°F for a 4-minute exposure and can be used 200 times.
Catalog Number
LCB056
Brand Name
VERIFY
Version/Model Number
LCB056
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
FRC
Product Code Name
Indicator, biological sterilization process
Public Device Record Key
08f83680-31ef-4d81-be2b-6802ca78c088
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
April 19, 2019
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 |