Identity
- Trade Name
- INTEGRA® VolTAC™ FDA UDI
- Generic Name
- Adhesive bandage FDA UDI
- Device Name
- Integra VolTAC Antimicrobial Wound Dressing is a single layer 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. FDA UDI
- Model / Reference
- VOLS0101 FDA UDI
- Description
- Integra VolTAC Antimicrobial Wound Dressing is a single layer 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780257851 FDA UDI
- 510(k) Number
- K130350 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Adhesive bandage FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Adhesive bandage
INTEGRA® VolTAC™ by Integra Lifesciences Corp. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K130350 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Integra Lifesciences Corp.
Sources (1)
- FDA UDI 1c50c63d-17b1-4def-a80e-8a3d1623e6d0 37 fields · synced May 31, 2026