Duns Number:960091929
Device Description: Vitale Silicone Super-Absorbent Dressings, 6" x 7", 10/box, 10 boxes/case, 2 cases/overpac Vitale Silicone Super-Absorbent Dressings, 6" x 7", 10/box, 10 boxes/case, 2 cases/overpack
Catalog Number
20267
Brand Name
Vitale
Version/Model Number
20267
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 31, 2018
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
8cd07e6a-6e03-4761-ba87-958ae2f77df3
Public Version Date
June 22, 2021
Public Version Number
6
DI Record Publish Date
June 26, 2017
Package DI Number
B492202673
Quantity per Package
30
Contains DI Package
B492202671
Package Discontinue Date
February 19, 2018
Package Status
Not 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 |