Levicyn Antipruritic Gel 85018

GUDID 00850015491573

Sonoma Pharmaceuticals, Inc.

Wound hydrogel dressing, non-antimicrobial

• Primary Device ID: 00850015491573
• NIH Device Record Key: 167b8a9e-30cd-4506-beb9-6128e1d38fef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Levicyn Antipruritic Gel
• Version Model Number: 85018
• Catalog Number: 85018
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Weight: 14 Gram
• Weight: 14 Gram
• Weight: 14 Gram
• Weight: 14 Gram
• Weight: 14 Gram
• Weight: 14 Gram
• Weight: 14 Gram
• Weight: 14 Gram
• Weight: 14 Gram
• Weight: 14 Gram
• Weight: 14 Gram
• Weight: 14 Gram
• Weight: 14 Gram
• Weight: 14 Gram
• Weight: 14 Gram

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850015491573 [Primary]
GS1	10850015491570 [Package]; Package: Box [12 Units]; In Commercial Distribution
GS1	20850015491577 [Package]; Contains: 10850015491570; Package: Case [6 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: 2022-12-12
• Device Publish Date: 2022-12-02

On-Brand Devices [Levicyn Antipruritic Gel]

• 20860452000355: 85019
• 00850015491573: 85018