AccessGUDID - DEVICE: INTEGRA® VolTAC™ (10381780257837)

GUDID

Device Identifier (DI) Information

Brand Name: INTEGRA® VolTAC™
Version or Model: VOLHD03
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780257837
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, wound, drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130350	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Dressing Diameter: 2 in (5 cm)
Device Size Text, specify: Adhesive Diameter: 3 in (7.5 cm)

Device Record Status

Public Device Record Key: a1d87253-8766-4c45-aedc-60821469e1e0
Public Version Date: September 22, 2020
Public Version Number: 4
DI Record Publish Date: July 21, 2016