Duns Number:960091929
Device Description: Vitale Sacral Silicone Dressings, 1/pouch, 5/box, 40 boxes/case
Catalog Number
20190
Brand Name
Vitale
Version/Model Number
20190
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
a87bd428-facc-4352-848d-dd465b0e56f0
Public Version Date
June 22, 2021
Public Version Number
4
DI Record Publish Date
August 22, 2018
Package DI Number
00856276008567
Quantity per Package
40
Contains DI Package
00856276008550
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 |