Duns Number:868205779
Device Description: The VERIFY Incubator is for exclusive use with VERIFY Assert Self-Contained Biological Ind The VERIFY Incubator is for exclusive use with VERIFY Assert Self-Contained Biological Indicators and VERIFY Process Challenge Devices.
Catalog Number
LCB030
Brand Name
VERIFY
Version/Model Number
LCB030
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 25, 2022
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
OWP
Product Code Name
Biological sterilization process indicator with recombinant-dna plasmid
Public Device Record Key
4e01c04d-bee9-4370-87ab-4caabd335f34
Public Version Date
April 25, 2022
Public Version Number
5
DI Record Publish Date
April 01, 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 |