Vivera Pharmaceuticals, Inc

GUDID 00372380000384

A non-sterile covering made of a silicone-based material (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of an elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; it may be washable. This is a reusable device after appropriate cleaning.

VIVERA PHARMACEUTICALS, INC.

Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable

• Primary Device ID: 00372380000384
• NIH Device Record Key: c7ee4b2e-a99b-4720-9905-bfe3fd82e4da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivera Pharmaceuticals, Inc
• Version Model Number: Silinoin
• Company DUNS: 081244342
• Company Name: VIVERA PHARMACEUTICALS, 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 949-234-6161
• Email: regulatory@viverapharma.com
• Phone: 949-234-6161
• Email: regulatory@viverapharma.com
• Phone: 949-234-6161
• Email: regulatory@viverapharma.com
• Phone: 949-234-6161
• Email: regulatory@viverapharma.com
• Phone: 949-234-6161
• Email: regulatory@viverapharma.com
• Phone: 949-234-6161
• Email: regulatory@viverapharma.com
• Phone: 949-234-6161
• Email: regulatory@viverapharma.com
• Phone: 949-234-6161
• Email: regulatory@viverapharma.com
• Phone: 949-234-6161
• Email: regulatory@viverapharma.com
• Phone: 949-234-6161
• Email: regulatory@viverapharma.com
• Phone: 949-234-6161
• Email: regulatory@viverapharma.com
• Phone: 949-234-6161
• Email: regulatory@viverapharma.com
• Phone: 949-234-6161
• Email: regulatory@viverapharma.com
• Phone: 949-234-6161
• Email: regulatory@viverapharma.com
• Phone: 949-234-6161
• Email: regulatory@viverapharma.com
• Phone: 949-234-6161
• Email: regulatory@viverapharma.com
• Phone: 949-234-6161
• Email: regulatory@viverapharma.com
• Phone: 949-234-6161
• Email: regulatory@viverapharma.com
• Phone: 949-234-6161
• Email: regulatory@viverapharma.com
• Phone: 949-234-6161
• Email: regulatory@viverapharma.com
• Phone: 949-234-6161
• Email: regulatory@viverapharma.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00372380000384 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003948

FDA Product Code

• MDA: Elastomer, Silicone, For Scar Management

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-11
• Device Publish Date: 2022-07-01

Devices Manufactured by VIVERA PHARMACEUTICALS, INC.

• 10372380000008 - szosil medical grade silicone sheeting gel for scars: 2024-02-16
• 00372380000384 - Vivera Pharmaceuticals, Inc: 2022-07-11A non-sterile covering made of a silicone-based material (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of an elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; it may be washable. This is a reusable device after appropriate cleaning.
• 00372380000384 - Vivera Pharmaceuticals, Inc: 2022-07-11 A non-sterile covering made of a silicone-based material (e.g., silicone gel) intended to be applied directly to the skin for th
• 00372380000315 - Vivera Pharmaceuticals: 2021-09-27 A non-sterile covering made of a silicone-based material (e.g., silicone gel) intended to be applied directly to the skin for th
• 00372380000322 - Vivera Pharmaceuticals: 2021-09-27 A non-sterile covering made of a silicone-based material (e.g., silicone gel) intended to be applied directly to the skin for th
• 00372380000018 - szosil medical grade silicone gel sheeting for scar: 2019-09-30
• 00372380000025 - szosil silicone stick: 2019-09-30
• 00372380000032 - szosil skin repair serum: 2019-09-30