Solarcaine Advanced Burn Relief Hydrogel 50410

GUDID 20365197504101

Sonoma Pharmaceuticals, Inc.

Wound hydrogel dressing, non-antimicrobial

• Primary Device ID: 20365197504101
• NIH Device Record Key: 2b9b2f33-2199-4038-9f57-71f0591b966b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solarcaine Advanced Burn Relief Hydrogel
• Version Model Number: 50410
• Catalog Number: 50410
• Company DUNS: 081642964
• Company Name: Sonoma 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: true
• 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: true

Device Dimensions

• Weight: 170 Gram
• Weight: 170 Gram
• Weight: 170 Gram
• Weight: 170 Gram
• Weight: 170 Gram
• Weight: 170 Gram
• Weight: 170 Gram
• Weight: 170 Gram
• Weight: 170 Gram
• Weight: 170 Gram
• Weight: 170 Gram
• Weight: 170 Gram

Device Identifiers

Device Issuing Agency	Device ID
GS1	00365197504107 [Primary]
GS1	10365197504104 [Package]; Package: Case [8 Units]; In Commercial Distribution
GS1	20365197504101 [Package]; Contains: 00365197504107; Package: Box [3 Units]; In Commercial Distribution

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2025-09-15
• Device Publish Date: 2025-09-05

On-Brand Devices [Solarcaine Advanced Burn Relief Hydrogel]

• 20365197504002: 86035
• 20365197504101: 50410