Duns Number:960091929
Device Description: Vitale Collagen Dressings, 4" x 4", 10/box, 10 boxes/case
Catalog Number
22044
Brand Name
Vitale
Version/Model Number
22044
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
-
Product Code
KGN
Product Code Name
Dressing, Wound, Collagen
Public Device Record Key
f9222cdf-1906-4452-be8c-588428b1a089
Public Version Date
November 01, 2021
Public Version Number
3
DI Record Publish Date
April 20, 2020
Package DI Number
00850005565437
Quantity per Package
10
Contains DI Package
00850005565420
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 |