Sensifine

GUDID 16972949026117

Hangzhou R&L Medical Device Co., Ltd

Scar-management dressing, reusable

• Primary Device ID: 16972949026117
• NIH Device Record Key: adb551fe-66e9-4a64-a0f6-e944163f8b45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sensifine
• Version Model Number: J-15cm×12cm
• Company DUNS: 415588794
• Company Name: Hangzhou R&L Medical Device Co., Ltd
• Device Count: 1
• 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: false
• 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	06972949026110 [Primary]
GS1	16972949026117 [Package]; Contains: 06972949026110; Package: [48 Units]; In Commercial Distribution

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: 2025-12-16
• Device Publish Date: 2025-12-08

On-Brand Devices [Sensifine]

• 16972949026124: SGX015
• 16972949026117: J-15cm×12cm
• 16972949026100: Hydrocolloid Bandage (Mixed Sizes). Each package contains a total of 11 patches: 9 circular patc
• 16972949026094: HD0101