Duns Number:961394798
Device Description: The PRO-Lite Sterilization Tray Mat, 25-inch x 11.75-inch, is used in V-PRO Low Temperatur The PRO-Lite Sterilization Tray Mat, 25-inch x 11.75-inch, is used in V-PRO Low Temperature Sterilization Systems and STERRAD NX, 100S and 100NX sterilizers.
Catalog Number
VP0078
Brand Name
Pro-Lite
Version/Model Number
VP0078
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
KCT
Product Code Name
Sterilization wrap containers, trays, cassettes & other accessories
Public Device Record Key
d0c6e6a4-8778-4758-b277-a9bd3e1b8728
Public Version Date
November 03, 2020
Public Version Number
5
DI Record Publish Date
February 01, 2018
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 |