OptraGate 2 757915WW

GUDID 07615208535907

OptraGate 2 Assortment

IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Dental cheek retractor, professional, single-use

• Primary Device ID: 07615208535907
• NIH Device Record Key: 9c575f28-ec6f-4353-ad84-45c08786a755
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptraGate 2
• Version Model Number: 757915WW
• Catalog Number: 757915WW
• Company DUNS: 448015938
• Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT
• Device Count: 80
• 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	07615208516982 [Primary]
GS1	07615208535907 [Unit of Use]

FDA Product Code

• EIF: ACCESSORIES, RETRACTOR, DENTAL

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: 2025-03-03
• Device Publish Date: 2025-02-21

On-Brand Devices [OptraGate 2]

• DVIV757914WW0: OptraGate 2 Small Refill / 80
• DVIV757912WW0: OptraGate 2 Regular Refill / 80
• 07615208526455: OptraGate 2 Test Pack 2x1
• 07615208535907: OptraGate 2 Assortment