Procellera Composite VHC-0404

GUDID 00810198030402

Procellera Composite OTC; 4"x4"

Vomaris Wound Care, Inc.

Bioelectric wound dressing

• Primary Device ID: 00810198030402
• NIH Device Record Key: e0ab9b2f-4464-47d3-a950-da95adc1f938
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procellera Composite
• Version Model Number: 4"x4"
• Catalog Number: VHC-0404
• 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: false

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810198030402 [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: 2022-11-28
• Device Publish Date: 2022-11-18

On-Brand Devices [Procellera Composite]

• 00894318002517: Procellera Composite Rx; 2.5" diameter
• 00894318002494: Procellera Composite Rx; 4' diameter
• 00894318002487: Procellera Composite Rx; 4"x4"
• 00894318002470: Procellera Composite Rx; 5"x6"
• 00894318002463: Procellera Composite Rx; 4.5"x10"
• 00894318002456: Procellera Composite Rx; 6"x11.5"
• 00810198030419: Procellera Composite OTC; 4' diameter
• 00810198030402: Procellera Composite OTC; 4"x4"
• 00810198030198: Procellera Composite Rx; 4.2"x7.5"
• 00810198030181: Procellera Composite Rx; 4.4"x9.6"