Duns Number:961394798
Device Description: The PRO-LITE Sterilization Tray, 12-inch x 11.75-inch x 4-inch is used with the V-PRO Low The PRO-LITE Sterilization Tray, 12-inch x 11.75-inch x 4-inch is used with the V-PRO Low Temperature Sterilization Systems and STERRAD NX, 100S and 100NX sterilizers.
Catalog Number
VP0051
Brand Name
PRO-LITE
Version/Model Number
VP0051
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
K160912,K183301,K183402,K160912,K183301,K183402
Product Code
KCT
Product Code Name
Sterilization wrap containers, trays, cassettes & other accessories
Public Device Record Key
b65928f7-8046-4c7d-b763-88b0c05d0f6f
Public Version Date
July 08, 2021
Public Version Number
2
DI Record Publish Date
April 23, 2021
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 |