Procellera Single Layer VSR-0303

GUDID 00894318002593

Procellera Single Layer Rx, 3" x 3"

Vomaris Wound Care, Inc.

Bioelectric wound dressing Bioelectric wound dressing Bioelectric wound dressing Bioelectric wound dressing Bioelectric wound dressing Bioelectric wound dressing Bioelectric wound dressing Bioelectric wound dressing Bioelectric wound dressing Bioelectric wound dressing Bioelectric wound dressing

• Primary Device ID: 00894318002593
• NIH Device Record Key: bc669ff4-6cf2-44a4-beb2-56c5c73021fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procellera Single Layer
• Version Model Number: 3" x 3"
• Catalog Number: VSR-0303
• 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	00894318002593 [Primary]
GS1	10894318002590 [Package]; Package: Box [10 Units]; In Commercial Distribution

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: 2022-11-28
• Device Publish Date: 2022-11-18

On-Brand Devices [Procellera Single Layer]

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• 00894318002616: Procellera Single Layer Rx, 2" x 2"
• 00894318002609: Procellera Single Layer Rx, 2" x 5"
• 00894318002593: Procellera Single Layer Rx, 3" x 3"
• 00894318002586: Procellera Single Layer Rx, 4" x 4"
• 00894318002579: Procellera Single Layer Rx, 5" x 5"
• 00810198030389: Procellera Single Layer OTC, 4"x 4"
• 00810198030372: Procellera Single Layer OTC, 2"x2"
• 00810198030358: Procellera Single Layer Rx 12" x 12"
• 00810198030327: Procellera Single Layer Rx 8" x 8"
• 00810198030013: Procellera Single Layer Rx, 4" x 8"