INTEGRA® VolTAC™

Basic Information

• Brand Name: INTEGRA® VolTAC™
• Primary DI: 10381780257882
• Version / Model: VOLS0303
• Company Name: Integra Lifesciences Corporation
• Labeler DUNS: 083171244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-21
• Public Version: 4
• Public Version Date: 2020-09-22
• Public Version Status: Update
• Public Device Record Key: 6c519d61-0f62-4b09-b171-fea7ca78a3ef

Device 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRO	Dressing, wound, drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
34864	Adhesive bandage	A sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30381780257886	GS1	BOX	10	In Commercial Distribution
Primary	10381780257882	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K130350	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Dressing Size: 3x3 in (7.5x7.5 cm)

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 68 – 77 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Excursions between 15C and 30C; brief exposure up to 40C if mean kinetic temp does not exceed 25C
• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius