Optragate Dry Control 768789

GUDID 07615208543506

OptraGate Dry TestPack / 1x2

IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Dental suction system cannula, single-use

• Primary Device ID: 07615208543506
• NIH Device Record Key: d53847f8-c88c-4891-9d89-438f273cfcdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optragate Dry Control
• Version Model Number: 768789
• Catalog Number: 768789
• Company DUNS: 448015938
• Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07615208536874 [Primary]
GS1	07615208543506 [Unit of Use]

FDA Product Code

• DYN: Mouthpiece, saliva ejector

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: 2025-12-12
• Device Publish Date: 2025-12-04

On-Brand Devices [Optragate Dry Control]

• 07615208543506: OptraGate Dry TestPack / 1x2
• 07615208584998: OptraGate Dry Control Refill / 60
• 07615208584981: OptraGate Dry Control Refill / 30