Prevue® 604103

GUDID EDEL6041030

Prevue® Yellow-Red Universal, Syringe 2.5g

DeltaMed GmbH

Dental composite resin

• Primary Device ID: EDEL6041030
• NIH Device Record Key: 362a2535-86c5-4d91-b2c4-d045320ee1dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prevue®
• Version Model Number: 604103
• Catalog Number: 604103
• Company DUNS: 344805101
• Company Name: DeltaMed GmbH
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7796041030 [Previous]
HIBCC	EDEL6041030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894477

FDA Product Code

• EMA: Cement, 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: 2023-06-20
• Device Publish Date: 2023-06-12

On-Brand Devices [Prevue®]

• EDEL6041070: Prevue® Pink Opaque, Syringe 2.5g
• EDEL6041060: Prevue® Yellow Opaque, Syringe 2.5g
• EDEL6041050: Prevue® White Opaque, Syringe 2.5g
• EDEL6041040: Prevue® Grey Light, Syringe 2.5g
• EDEL6041030: Prevue® Yellow-Red Universal, Syringe 2.5g
• EDEL6041020: Prevue® Yellow-Red Light, Syringe 2.5g
• EDEL6041010: Prevue® Clear, Syringe 2.5g