Duns Number:960091929
Device Description: Xeroform Petrolatum Gauze Dressings, 4" x 4", 25/box, 12 boxes/case
Catalog Number
57404
Brand Name
Vitale
Version/Model Number
57404
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAD
Product Code Name
Dressing, Wound, Occlusive
Public Device Record Key
78298110-d540-43b3-9ba2-86003b6ab478
Public Version Date
June 21, 2022
Public Version Number
2
DI Record Publish Date
March 15, 2019
Package DI Number
10850005565090
Quantity per Package
12
Contains DI Package
00850005565093
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 |