Periovance Dry Mouth Gel

GUDID 00850058655055

40mL Dry Mouth Gel

ORABIO, INC.

Artificial saliva

• Primary Device ID: 00850058655055
• NIH Device Record Key: 5335c1ec-bc7d-4b91-af72-eca4cda956a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Periovance Dry Mouth Gel
• Version Model Number: 7374-900P
• 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	00850058655055 [Primary]
GS1	00850058655062 [Package]; Package: Case [12 Units]; In Commercial Distribution
GS1	00850058655079 [Package]; Contains: 00850058655062; Package: Master Carton [12 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