Duns Number:960091929
Device Description: Vitale Silicone Composite Dressings, 2" x 3", 1/pouch, 30/box, 10 boxes/case, 4 cases/over Vitale Silicone Composite Dressings, 2" x 3", 1/pouch, 30/box, 10 boxes/case, 4 cases/overpack
Catalog Number
24203
Brand Name
Vitale
Version/Model Number
24203
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
NAD
Product Code Name
Dressing, Wound, Occlusive
Public Device Record Key
132e14bd-3577-4ead-8c22-f240163dbfc7
Public Version Date
November 08, 2021
Public Version Number
1
DI Record Publish Date
October 31, 2021
Package DI Number
00850005565918
Quantity per Package
30
Contains DI Package
00850005565901
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 59 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 10 |