Duns Number:960091929
Device Description: Calcium Alginate Dressings with Antibacterial Silver, 4" x 8"
Catalog Number
20548
Brand Name
Vitale
Version/Model Number
20548
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)
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
b756f225-2a77-4e52-95a5-ae5f35272a36
Public Version Date
February 14, 2022
Public Version Number
1
DI Record Publish Date
February 06, 2022
Package DI Number
00850005565253
Quantity per Package
5
Contains DI Package
00850005565246
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 |