Duns Number:083171244
Device Description: Integra VolTAC Antimicrobial Wound Dressing Composite is a three layer composite dressing. Integra VolTAC Antimicrobial Wound Dressing Composite is a three layer composite dressing. VolTAC consists of a polyester substrate containing elemental silver and zinc applied on the surface in a dot-matrix pattern. In the presence of a conductive medium (e.g. wound exudate, water-based wound hydrogel, sterile saline or sterile water), silver and zinc in the dressing generate microcurrents at the dressing surface which helps preserve the dressing and minimizes or prevents the growth of microorganisms within the dressing.
Catalog Number
-
Brand Name
INTEGRA® VolTAC™
Version/Model Number
VOLH4510
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"
Yes
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
K130350,K130350
Product Code
FRO
Product Code Name
Dressing, wound, drug
Public Device Record Key
89c5b554-1cb3-4771-9ebf-16ed34b06ea8
Public Version Date
September 22, 2020
Public Version Number
4
DI Record Publish Date
July 21, 2016
Package DI Number
30381780257817
Quantity per Package
5
Contains DI Package
10381780257813
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 | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| 3 | A medical device with high risk that requires premarket approval | 17 |
| U | Unclassified | 32 |