DUO-GUN 4007-2010

GUDID 08806383557238

Duo-Gun is an endodontic device that heat-soften specially-formulated Gutta Percha and enable vertical injection of softened Gutta Percha through the disposable obturation tip into the root canal.

DiaDent Group International

Endodontic obturation system

• Primary Device ID: 08806383557238
• NIH Device Record Key: 0ab57e2b-c844-42a7-8399-cf1bcb268a66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUO-GUN
• Version Model Number: DUO-GUN HANDPIECE
• Catalog Number: 4007-2010
• Company DUNS: 687789453
• Company Name: DiaDent Group International
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806383557238 [Primary]

FDA Product Code

• EKR: Plugger, Root Canal, Endodontic

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: 2020-06-03
• Device Publish Date: 2020-05-26

On-Brand Devices [DUO-GUN]

• 08806383557269: Duo-Gun is an endodontic device that heat-soften specially-formulated Gutta Percha and enable ve
• 08806383557252: Duo-Gun is an endodontic device that heat-soften specially-formulated Gutta Percha and enable ve
• 08806383557245: Duo-Gun is an endodontic device that heat-soften specially-formulated Gutta Percha and enable ve
• 08806383557238: Duo-Gun is an endodontic device that heat-soften specially-formulated Gutta Percha and enable ve
• 08806383557221: Duo-Gun is an endodontic device that heat-soften specially-formulated Gutta Percha and enable ve
• 08806383557092: Duo-Gun is an endodontic device that heat-soften specially-formulated Gutta Percha and enable ve
• 08806383556699: Duo-Gun is an endodontic device that heat-soften specially-formulated Gutta Percha and enable ve
• 08806383556682: Duo-Gun is an endodontic device that heat-soften specially-formulated Gutta Percha and enable ve
• 08806383586313: Duo-Gun is an endodontic device that heat-soften specially-formulated Gutta Percha and enable ve