PowerHeal Single Layer PSK-0202

GUDID 00810198031560

PowerHeal Single Layer, 2" x 2"

Vomaris Wound Care, Inc.

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• Primary Device ID: 00810198031560
• NIH Device Record Key: 24f963c5-0ccc-41a5-bc39-a9107550806d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PowerHeal Single Layer
• Version Model Number: 2" x 2"
• Catalog Number: PSK-0202
• 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: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810198031560 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160783

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 Single Layer]

• 00810198031577: PowerHeal Single Layer, 4"x 4"
• 00810198031560: PowerHeal Single Layer, 2" x 2"