Duns Number:960091929
Device Description: Calcium Alginate Dressings with Antibacterial Silver, 4" x 8", 5/box, 10 boxes/case
Catalog Number
20558
Brand Name
Vitale STRONG
Version/Model Number
20558
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"
Yes
For Single-Use
Yes
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
K143335,K143335,K143335
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
50260de1-6b35-4122-942a-9c3e54ec7b9b
Public Version Date
January 24, 2022
Public Version Number
1
DI Record Publish Date
January 16, 2022
Package DI Number
00850005565819
Quantity per Package
5
Contains DI Package
00850005565796
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 |