Duns Number:960091929
Device Description: Vitale Calcium Alginate Dressings, 4" x 4", 10/box, 10 boxes/case
Catalog Number
20644
Brand Name
Vitale
Version/Model Number
20644
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
-
Product Code
NAC
Product Code Name
Dressing,Wound,Hydrophilic
Public Device Record Key
e50c0e73-99bc-4194-8230-285f226d6cfb
Public Version Date
July 22, 2021
Public Version Number
4
DI Record Publish Date
June 09, 2017
Package DI Number
B492206442
Quantity per Package
10
Contains DI Package
B492206441
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 |