Procellera Pin Site VPK-FD20

GUDID 00810198030822

Procellera Pin Site Rx; 2" diameter

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: 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