szosil medical grade silicone gel sheeting for scar

GUDID 00372380000018

VIVERA PHARMACEUTICALS, INC.

Scar management dressing, single-use, non-sterile Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use

• Primary Device ID: 00372380000018
• NIH Device Record Key: 49bf66f1-1472-4cef-b670-f9869d70710d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: szosil medical grade silicone gel sheeting for scar
• Version Model Number: 1
• 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: false
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00372380000018 [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: 2019-09-30
• Device Publish Date: 2019-09-20

Devices Manufactured by VIVERA PHARMACEUTICALS, INC.

• 10372380000008 - szosil medical grade silicone sheeting gel for scars: 2024-02-16
• 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
• 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