Duns Number:961394798
Device Description: The Vis-U-All High Temperature Heat Seal Sterilization Pouch is validated for use with eth The Vis-U-All High Temperature Heat Seal Sterilization Pouch is validated for use with ethylene oxide and steam sterilization.
Catalog Number
883515
Brand Name
NA
Version/Model Number
883515
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
795b45e8-858f-496a-96ce-bc21ac9d1190
Public Version Date
November 03, 2020
Public Version Number
6
DI Record Publish Date
January 27, 2017
Package DI Number
50724995152456
Quantity per Package
5
Contains DI Package
10724995152458
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 |