Procellera Pin Site VPK-FD20

GUDID 00810198030822

Procellera Pin Site Rx; 2" diameter

Vomaris Wound Care, Inc.

Bioelectric wound dressing

• Primary Device ID: 00810198030822
• NIH Device Record Key: 457690aa-7c10-4ae3-89e7-ebcaf6c3d859
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procellera Pin Site
• Version Model Number: 2" Diam
• Catalog Number: VPK-FD20
• 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	00810198030822 [Primary]
GS1	10810198030829 [Package]; Package: Box [5 Units]; In Commercial Distribution

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

Devices Manufactured by Vomaris Wound Care, Inc.

• 00810198031553 - PowerHeal Energel: 2024-03-11 Energel - Single Sterile Sachet 7.5g / 0.26oz
• 00810198031447 - PowerHeal Kit: 2024-03-08 PowerHeal Kit, 4"x4" 3-layer clear adhesive & Energel
• 00810198031454 - PowerHeal Kit: 2024-03-08 PowerHeal Kit, 6"x6" 3-layer & Energel
• 00810198031461 - PowerHeal Kit: 2024-03-08 PowerHeal Kit, 2.3"x 3.5" 3-layer clear adhesive & Energel
• 00810198031478 - PowerHeal Kit: 2024-03-08 PowerHeal Combo Kit, 4"x4", 6"x6", 2.3"x3.5" (3-layer clear adhesive) & Energel
• 00810198031485 - PowerHeal Kit: 2024-03-08 PowerHeal Kit, 2"x2" Single Layer & Energel
• 00810198031492 - PowerHeal Kit: 2024-03-08 PowerHeal, 4"x4" Single Layer, & Energel
• 00810198031508 - PowerHeal Kit: 2024-03-08 PowerHeal Kit, 2"x2" Single Layer, Energel & Tegaderm