Duns Number:813116209
Device Description: The Amsco V-PRO maX Low Temperature Sterilization System is intended for use in the termin The Amsco V-PRO maX Low Temperature Sterilization System is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) metal and nonmetal medical devices used in Healthcare Facilities.
Catalog Number
VP30003101
Brand Name
AMSCO V-PRO
Version/Model Number
V-PRO maX
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 27, 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
-
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
K102330,K112760,K112813,K120632,K131120,K160433,K162413,K172319,K172754,K190103
Product Code
MLR
Product Code Name
Sterilizer, chemical
Public Device Record Key
cf7af2ac-dfba-4335-a0cd-07399c8ed0ce
Public Version Date
August 27, 2021
Public Version Number
3
DI Record Publish Date
April 16, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 548 |