Duns Number:960091929
Device Description: Vitale Calcium Alginate Dressings with Antibacterial Silver, 2"x2", 10/box, 10 boxes/case
Catalog Number
20522
Brand Name
Vitale
Version/Model Number
20522
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K143335,K143335,K143335
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
f0e4f867-8b46-42e8-ad14-bf51d36a1528
Public Version Date
July 22, 2021
Public Version Number
5
DI Record Publish Date
May 10, 2017
Package DI Number
B492205222
Quantity per Package
10
Contains DI Package
B492205221
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 | 59 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 10 |