Rystora® Scar Sheets

GUDID 04711182607029

FORTUNE MEDICAL INSTRUMENT CORP.

Scar management dressing, reusable

• Primary Device ID: 04711182607029
• NIH Device Record Key: f334a983-b486-44f7-8fd8-8056c5ec7d03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rystora® Scar Sheets
• Version Model Number: SA101812
• Company DUNS: 656763489
• Company Name: FORTUNE MEDICAL INSTRUMENT CORP.
• Device Count: 12
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04711182607029 [Unit of Use]
GS1	14711182607026 [Primary]

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: 2021-12-22
• Device Publish Date: 2021-12-13

On-Brand Devices [Rystora® Scar Sheets]

• 14711182628779: SA042501
• 04711182607029: SA101812
• 04711182607012: SA050712
• 04711182607005: SA042512
• 14711182628762: SA050701
• 14711182628755: SA101801