Solarcaine Advanced Burn Relief Hydrogel 86035

GUDID 20365197504002

Sonoma Pharmaceuticals, Inc.

Wound hydrogel dressing, non-antimicrobial

• Primary Device ID: 20365197504002
• NIH Device Record Key: ceae5951-04d5-4720-9b28-084356e5be31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solarcaine Advanced Burn Relief Hydrogel
• Version Model Number: 86035
• Catalog Number: 86035
• 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
• Weight: 170 Gram
• Weight: 170 Gram

Device Identifiers

Device Issuing Agency	Device ID
GS1	00365197504008 [Primary]
GS1	10365197504005 [Package]; Package: Case [8 Units]; In Commercial Distribution
GS1	20365197504002 [Package]; Contains: 00365197504008; 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: 2025-07-30
• Device Publish Date: 2025-07-22

Devices Manufactured by Sonoma Pharmaceuticals, Inc.

• 20365197504002 - Solarcaine Advanced Burn Relief Hydrogel: 2025-07-30
• 20365197504002 - Solarcaine Advanced Burn Relief Hydrogel: 2025-07-30
• 20365197851106 - Bactine Antimicrobial Wound Care Hydrogel: 2025-07-30
• 10850015491839 - PhaseOne Antimicrobial Solution: 2025-07-18
• 10860009268606 - PhaseOne Antimicrobial Solution: 2025-07-18
• 00860009268616 - PhaseOne Antimicrobial Solution: 2025-07-18
• 10365197409300 - A+D Antimicrobial Hydrogel Spray: 2025-06-18
• 20198715994272 - Advanced Scar & Wound Hydrogel: 2025-05-15
• 20850015491782 - Rejuvacyn Plus Dermal Spray: 2025-05-15