INTEGRA® VolTAC™

GUDID 30381780257930

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.

Integra Lifesciences Corporation

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• Primary Device ID: 30381780257930
• NIH Device Record Key: d88530cb-08bd-46bc-b0b1-b8bbf88831f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTEGRA® VolTAC™
• Version Model Number: VOLS1212
• Company DUNS: 083171244
• Company Name: Integra Lifesciences Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions between 15C and 30C; brief exposure up to 40C if mean kinetic temp does not exceed 25C
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions between 15C and 30C; brief exposure up to 40C if mean kinetic temp does not exceed 25C
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions between 15C and 30C; brief exposure up to 40C if mean kinetic temp does not exceed 25C
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions between 15C and 30C; brief exposure up to 40C if mean kinetic temp does not exceed 25C
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions between 15C and 30C; brief exposure up to 40C if mean kinetic temp does not exceed 25C
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions between 15C and 30C; brief exposure up to 40C if mean kinetic temp does not exceed 25C
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions between 15C and 30C; brief exposure up to 40C if mean kinetic temp does not exceed 25C
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions between 15C and 30C; brief exposure up to 40C if mean kinetic temp does not exceed 25C
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions between 15C and 30C; brief exposure up to 40C if mean kinetic temp does not exceed 25C
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions between 15C and 30C; brief exposure up to 40C if mean kinetic temp does not exceed 25C
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions between 15C and 30C; brief exposure up to 40C if mean kinetic temp does not exceed 25C
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions between 15C and 30C; brief exposure up to 40C if mean kinetic temp does not exceed 25C
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions between 15C and 30C; brief exposure up to 40C if mean kinetic temp does not exceed 25C
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursions between 15C and 30C; brief exposure up to 40C if mean kinetic temp does not exceed 25C
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780257936 [Primary]
GS1	30381780257930 [Package]; Contains: 10381780257936; Package: BOX [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130350

FDA Product Code

• FRO: Dressing, wound, drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-22
• Device Publish Date: 2016-07-21

On-Brand Devices [INTEGRA® VolTAC™]

• 30381780257961: Integra VolTAC Antimicrobial Wound Dressing is a single layer dressing. VolTAC consists of a pol
• 30381780257954: Integra VolTAC Antimicrobial Wound Dressing is a single layer dressing. VolTAC consists of a pol
• 30381780257930: Integra VolTAC Antimicrobial Wound Dressing is a single layer dressing. VolTAC consists of a pol
• 50381780257903: Integra VolTAC Antimicrobial Wound Dressing is a single layer dressing. VolTAC consists of a pol
• 30381780257893: Integra VolTAC Antimicrobial Wound Dressing is a single layer dressing. VolTAC consists of a pol
• 30381780257886: Integra VolTAC Antimicrobial Wound Dressing is a single layer dressing. VolTAC consists of a pol
• 30381780257879: Integra VolTAC Antimicrobial Wound Dressing is a single layer dressing. VolTAC consists of a pol
• 30381780257862: Integra VolTAC Antimicrobial Wound Dressing is a single layer dressing. VolTAC consists of a pol
• 30381780257855: Integra VolTAC Antimicrobial Wound Dressing is a single layer dressing. VolTAC consists of a pol
• 30381780257848: Integra VolTAC Antimicrobial Wound Dressing Composite is a three layer composite dressing. VolTA
• 30381780257831: Integra VolTAC Antimicrobial Wound Dressing Composite is a three layer composite dressing. VolTA
• 30381780257824: Integra VolTAC Antimicrobial Wound Dressing Composite is a three layer composite dressing. VolTA
• 30381780257817: Integra VolTAC Antimicrobial Wound Dressing Composite is a three layer composite dressing. VolTA
• 30381780257800: Integra VolTAC Antimicrobial Wound Dressing Composite is a three layer composite dressing. VolTA
• 30381780257794: Integra VolTAC Antimicrobial Wound Dressing Composite is a three layer composite dressing. VolTA
• 30381780257787: Integra VolTAC Antimicrobial Wound Dressing Composite is a three layer composite dressing. VolTA