Duns Number:961394798
Device Description: The Vis-U-All Low Temperature Sterilization Tubing is used in the V-PRO Low Temperature St The Vis-U-All Low Temperature Sterilization Tubing is used in the V-PRO Low Temperature Sterilization Systems and STERRAD NX, 100S and 100NX sterilizers.
Catalog Number
882031
Brand Name
NA
Version/Model Number
882031
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
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
FRG
Product Code Name
Wrap, sterilization
Public Device Record Key
6d411ce0-143c-44ef-b5c3-f621fc98c9ab
Public Version Date
November 03, 2020
Public Version Number
7
DI Record Publish Date
January 17, 2017
Package DI Number
50724995003192
Quantity per Package
10
Contains DI Package
00724995003197
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |