Duns Number:961394798
Device Description: The VERIFY V24 Challenge Pack is for qualifications testing of the V-PRO Low Temperature S The VERIFY V24 Challenge Pack is for qualifications testing of the V-PRO Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.
Catalog Number
LCB005
Brand Name
VERIFY
Version/Model Number
LCB005
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 19, 2021
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
FRC
Product Code Name
Indicator, biological sterilization process
Public Device Record Key
d7ddc1cf-9510-4765-8f98-e75f5a9eba46
Public Version Date
April 19, 2021
Public Version Number
7
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 |