Rystora Silicone Scar Gel

GUDID 04711182608156

FORTUNE MEDICAL INSTRUMENT CORP.

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• Primary Device ID: 04711182608156
• NIH Device Record Key: 495f9404-5b43-4d22-8d18-05d566b4a539
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rystora Silicone Scar Gel
• Version Model Number: SGA01501
• Company DUNS: 656763489
• Company Name: FORTUNE MEDICAL INSTRUMENT CORP.
• Device Count: 24
• 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: true
• 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	04711182608156 [Unit of Use]
GS1	14711182608153 [Primary]

FDA Product Code

• PFP: Silicone Hydrogel 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: 2022-01-07
• Device Publish Date: 2021-12-30

Devices Manufactured by FORTUNE MEDICAL INSTRUMENT CORP.

• 14711182608306 - Silicone T Drainage Set With Eyes: 2023-11-01
• 14711182608313 - Silicone T Drainage Set With Eyes: 2023-11-01
• 04711182608163 - Rystora Skin Protector-Spray: 2022-02-08
• 04710961934844 - Silicone C.W.V. Reservoir: 2022-02-08
• 04710961934851 - Silicone C.W.V. Reservoir: 2022-02-08
• 04710961934868 - Silicone C.W.V. Reservoir: 2022-02-08
• 04710961934875 - Silicone C.W.V. Reservoir (Top Outlet): 2022-02-08
• 04710961934882 - Silicone C.W.V. Reservoir: 2022-02-08