Periovance Dry Mouth Gel

GUDID 00850058655109

Dry Mouth Gel - Mini

ORABIO, INC.

Artificial saliva

• Primary Device ID: 00850058655109
• NIH Device Record Key: c00555d9-5818-42ca-801e-b8c468c36600
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Periovance Dry Mouth Gel
• Version Model Number: 7374-901P
• Company DUNS: 119105756
• Company Name: ORABIO, 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: false
• Single Use: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00850058655086 [Primary]
GS1	00850058655093 [Package]; Contains: 00850058655086; Package: Case [10 Units]; In Commercial Distribution
GS1	00850058655109 [Package]; Contains: 00850058655086; Package: Master Carton [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072306

FDA Product Code

• LFD: Saliva, Artificial

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: 2025-04-17
• Device Publish Date: 2025-04-09

On-Brand Devices [Periovance Dry Mouth Gel]

• 00850058655109: Dry Mouth Gel - Mini
• 00850058655055: 40mL Dry Mouth Gel