Duns Number:813116209
Device Description: The V-PRO maX 2 Low Temperature Sterilization System is used in the terminal sterilization The V-PRO maX 2 Low Temperature Sterilization System is used in the terminal sterilization of properly prepared, cleaned, rinsed and dried medical devices utilizing VAPROX HC Sterilant.
Catalog Number
VP50002101
Brand Name
V-PRO
Version/Model Number
max 2
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K172754,K190103,K222093,K222543,K222849
Product Code
MLR
Product Code Name
Sterilizer, chemical
Public Device Record Key
b031f7f0-ca2f-44d2-90d7-60bac6382703
Public Version Date
October 27, 2022
Public Version Number
4
DI Record Publish Date
August 23, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 548 |