Duns Number:960091929
Device Description: Vitale Sacral Hydrocolloid Dressing, 6x7, 1/pouch, 10/box, 10 boxes/case
Catalog Number
21290
Brand Name
Vitale
Version/Model Number
21290
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
NAD
Product Code Name
Dressing,Wound,Occlusive
Public Device Record Key
374412e5-7f82-4c2c-bdd5-5ec429771db3
Public Version Date
July 22, 2021
Public Version Number
4
DI Record Publish Date
May 04, 2017
Package DI Number
B492212901
Quantity per Package
5
Contains DI Package
B492212900
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 |