PowerHeal 3-layer clear adhesive PFK-6060

GUDID 00810198031546

PowerHeal 3-layer clear adhesive, 6" x 6" "

Vomaris Wound Care, Inc.

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• Primary Device ID: 00810198031546
• NIH Device Record Key: 6c8062ce-e6af-4405-8f74-ad3ec4f800d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PowerHeal 3-layer clear adhesive
• Version Model Number: 6" x 6"
• Catalog Number: PFK-6060
• Company DUNS: 080126901
• Company Name: Vomaris Wound Care, Inc.
• 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: true

Customer Support Contacts

• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com
• Phone: (480) 921-4948
• Email: customerservice@vomaris.com

Device Dimensions

• Length: 6 Inch
• Width: 6 Inch
• Length: 6 Inch
• Width: 6 Inch
• Length: 6 Inch
• Width: 6 Inch
• Length: 6 Inch
• Width: 6 Inch
• Length: 6 Inch
• Width: 6 Inch
• Length: 6 Inch
• Width: 6 Inch
• Length: 6 Inch
• Width: 6 Inch
• Length: 6 Inch
• Width: 6 Inch
• Length: 6 Inch
• Width: 6 Inch
• Length: 6 Inch
• Width: 6 Inch
• Length: 6 Inch
• Width: 6 Inch
• Length: 6 Inch
• Width: 6 Inch
• Length: 6 Inch
• Width: 6 Inch
• Length: 6 Inch
• Width: 6 Inch
• Length: 6 Inch
• Width: 6 Inch
• Length: 6 Inch
• Width: 6 Inch
• Length: 6 Inch
• Width: 6 Inch
• Length: 6 Inch
• Width: 6 Inch
• Length: 6 Inch
• Width: 6 Inch
• Length: 6 Inch
• Width: 6 Inch
• Length: 6 Inch
• Width: 6 Inch
• Length: 6 Inch
• Width: 6 Inch
• Length: 6 Inch
• Width: 6 Inch
• Length: 6 Inch
• Width: 6 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810198031546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180533

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-08
• Device Publish Date: 2024-02-29

On-Brand Devices [PowerHeal 3-layer clear adhesive]

• 00810198031546: PowerHeal 3-layer clear adhesive, 6" x 6" "
• 00810198031522: PowerHeal 3-layer clear adhesive, 2.3 x 3.5